Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2025-12-25 @ 8:35 PM
Study NCT ID:
NCT07086469
Status:
RECRUITING
Last Update Posted:
2025-11-17
First Post:
2025-07-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Surufatinib in Combination With Neoadjuvant Chemo-immunotherapy and Concurrent Chemoradiotherapy for Patients With Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077277', 'term': 'Esophageal Squamous Cell Carcinoma'}], 'ancestors': [{'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D018307', 'term': 'Neoplasms, Squamous Cell'}, {'id': 'D004938', 'term': 'Esophageal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 69}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2029-07-19', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-13', 'studyFirstSubmitDate': '2025-07-15', 'studyFirstSubmitQcDate': '2025-07-24', 'lastUpdatePostDateStruct': {'date': '2025-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-07-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '2-year progression-free survival rate', 'timeFrame': '2 years', 'description': 'The 2-year progression-free survival rate refers to the proportion of patients who remain alive without evidence of disease progression at 24 months after initiation of treatment.'}], 'secondaryOutcomes': [{'measure': 'Median overall survival (OS)', 'timeFrame': '2 years', 'description': 'The time from the start of treatment to death from any cause.'}, {'measure': 'Objective Response Rate (ORR)', 'timeFrame': '2 months after CCRT', 'description': 'The objective response rate refers to the proportion of patients with a measurable reduction in tumor burden, including complete response (CR) and partial response (PR), as defined by standardized criteria such as RECIST (Response Evaluation Criteria in Solid Tumors).'}, {'measure': 'Locoregional Progression-Free Survival (LRPFS)', 'timeFrame': '2 years', 'description': 'LRPFS is defined as the time from the start of treatment to the first occurrence of locoregional disease progression or death from any cause.'}, {'measure': 'Distant Metastasis-Free Survival (DMFS)', 'timeFrame': '2 years', 'description': 'DMFS refers to the time from treatment initiation to the first occurrence of distant metastasis or death from any cause. It reflects the effectiveness of systemic disease control.'}, {'measure': 'Treatment-related adverse events', 'timeFrame': '1 year after treatment', 'description': 'The assessment of treatment-related adverse events (AEs), including their type, severity, frequency, and impact on patients.'}, {'measure': 'Patient-reported quality of life', 'timeFrame': '1 year after treatment', 'description': 'Quality of life assessed using the EORTC Quality of Life Core Questionnaire (QLQ-C30).'}, {'measure': 'Patient-reported esophageal-specific symptoms', 'timeFrame': '1 year after treatment', 'description': 'Esophageal-specific symptoms assessed using EORTC QLQ-OES18 questionnaire.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Toripalimab', 'Surufatinib', 'Neoadjuvant Immunochemotherapy', 'Chemoradiotherapy', 'Esophageal Squamous Cell Carcinoma'], 'conditions': ['Toripalimab', 'Surufatinib', 'Neoadjuvant Immunochemotherapy', 'Chemoradiotherapy', 'Esophageal Squamous Cell Carcinoma']}, 'referencesModule': {'references': [{'pmid': '38713205', 'type': 'BACKGROUND', 'citation': 'Zhang P, Chen Z, Shi S, Li Z, Ye F, Song L, Zhang Y, Yin F, Zhang X, Xu J, Cheng Y, Su W, Shi M, Fan S, Tan P, Zhong C, Lu M, Shen L. Efficacy and safety of surufatinib plus toripalimab, a chemotherapy-free regimen, in patients with advanced gastric/gastroesophageal junction adenocarcinoma, esophageal squamous cell carcinoma, or biliary tract cancer. Cancer Immunol Immunother. 2024 May 7;73(7):119. doi: 10.1007/s00262-024-03677-7.'}, {'pmid': '32966811', 'type': 'BACKGROUND', 'citation': 'Xu J, Shen L, Zhou Z, Li J, Bai C, Chi Y, Li Z, Xu N, Li E, Liu T, Bai Y, Yuan Y, Li X, Wang X, Chen J, Ying J, Yu X, Qin S, Yuan X, Zhang T, Deng Y, Xiu D, Cheng Y, Tao M, Jia R, Wang W, Li J, Fan S, Peng M, Su W. Surufatinib in advanced extrapancreatic neuroendocrine tumours (SANET-ep): a randomised, double-blind, placebo-controlled, phase 3 study. Lancet Oncol. 2020 Nov;21(11):1500-1512. doi: 10.1016/S1470-2045(20)30496-4. Epub 2020 Sep 20.'}, {'pmid': '32966810', 'type': 'BACKGROUND', 'citation': 'Xu J, Shen L, Bai C, Wang W, Li J, Yu X, Li Z, Li E, Yuan X, Chi Y, Yin Y, Lou W, Xu N, Bai Y, Zhang T, Xiu D, Wang X, Yuan Y, Chen J, Qin S, Jia R, Lu M, Cheng Y, Zhou Z, Li J, He J, Su W. Surufatinib in advanced pancreatic neuroendocrine tumours (SANET-p): a randomised, double-blind, placebo-controlled, phase 3 study. Lancet Oncol. 2020 Nov;21(11):1489-1499. doi: 10.1016/S1470-2045(20)30493-9. Epub 2020 Sep 20.'}, {'pmid': '33788183', 'type': 'BACKGROUND', 'citation': 'Syed YY. Surufatinib: First Approval. Drugs. 2021 Apr;81(6):727-732. doi: 10.1007/s40265-021-01489-y.'}, {'pmid': '27531478', 'type': 'BACKGROUND', 'citation': 'Wang J, Yu JP, Wang JL, Ni XC, Sun ZQ, Sun W, Nie B, Jiang JT, Sun SP, Wu CP. [Pathologic response and changes of serum VEGF during chemoradiotherapy may predict prognosis in non-surgical patients with esophageal carcinoma]. Zhonghua Zhong Liu Za Zhi. 2016 Aug;38(8):589-95. doi: 10.3760/cma.j.issn.0253-3766.2016.08.005. Chinese.'}, {'pmid': '36990609', 'type': 'BACKGROUND', 'citation': 'Zhu Y, Wen J, Li Q, Chen B, Zhao L, Liu S, Yang Y, Wang S, Lv Y, Li J, Zhang L, Hu Y, Liu M, Xi M. Toripalimab combined with definitive chemoradiotherapy in locally advanced oesophageal squamous cell carcinoma (EC-CRT-001): a single-arm, phase 2 trial. Lancet Oncol. 2023 Apr;24(4):371-382. doi: 10.1016/S1470-2045(23)00060-8.'}, {'pmid': '25640628', 'type': 'BACKGROUND', 'citation': 'Shinoda M, Ando N, Kato K, Ishikura S, Kato H, Tsubosa Y, Minashi K, Okabe H, Kimura Y, Kawano T, Kosugi S, Toh Y, Nakamura K, Fukuda H; Japan Clinical Oncology Group. Randomized study of low-dose versus standard-dose chemoradiotherapy for unresectable esophageal squamous cell carcinoma (JCOG0303). Cancer Sci. 2015 Apr;106(4):407-12. doi: 10.1111/cas.12622. Epub 2015 Mar 9.'}, {'pmid': '28687830', 'type': 'BACKGROUND', 'citation': 'Suntharalingam M, Winter K, Ilson D, Dicker AP, Kachnic L, Konski A, Chakravarthy AB, Anker CJ, Thakrar H, Horiba N, Dubey A, Greenberger JS, Raben A, Giguere J, Roof K, Videtic G, Pollock J, Safran H, Crane CH. Effect of the Addition of Cetuximab to Paclitaxel, Cisplatin, and Radiation Therapy for Patients With Esophageal Cancer: The NRG Oncology RTOG 0436 Phase 3 Randomized Clinical Trial. JAMA Oncol. 2017 Nov 1;3(11):1520-1528. doi: 10.1001/jamaoncol.2017.1598.'}, {'pmid': '34101496', 'type': 'BACKGROUND', 'citation': 'Hulshof MCCM, Geijsen ED, Rozema T, Oppedijk V, Buijsen J, Neelis KJ, Nuyttens JJME, van der Sangen MJC, Jeene PM, Reinders JG, van Berge Henegouwen MI, Thano A, van Hooft JE, van Laarhoven HWM, van der Gaast A. Randomized Study on Dose Escalation in Definitive Chemoradiation for Patients With Locally Advanced Esophageal Cancer (ARTDECO Study). J Clin Oncol. 2021 Sep 1;39(25):2816-2824. doi: 10.1200/JCO.20.03697. Epub 2021 Jun 8.'}, {'pmid': '24556041', 'type': 'BACKGROUND', 'citation': 'Conroy T, Galais MP, Raoul JL, Bouche O, Gourgou-Bourgade S, Douillard JY, Etienne PL, Boige V, Martel-Lafay I, Michel P, Llacer-Moscardo C, Francois E, Crehange G, Abdelghani MB, Juzyna B, Bedenne L, Adenis A; Federation Francophone de Cancerologie Digestive and UNICANCER-GI Group. Definitive chemoradiotherapy with FOLFOX versus fluorouracil and cisplatin in patients with oesophageal cancer (PRODIGE5/ACCORD17): final results of a randomised, phase 2/3 trial. Lancet Oncol. 2014 Mar;15(3):305-14. doi: 10.1016/S1470-2045(14)70028-2. Epub 2014 Feb 18.'}, {'pmid': '35190815', 'type': 'BACKGROUND', 'citation': 'Xu Y, Dong B, Zhu W, Li J, Huang R, Sun Z, Yang X, Liu L, He H, Liao Z, Guan N, Kong Y, Wang W, Chen J, He H, Qiu G, Zeng M, Pu J, Hu W, Bao Y, Liu Z, Ma J, Jiang H, Du X, Hu J, Zhuang T, Cai J, Huang J, Tao H, Liu Y, Liang X, Zhou J, Tao G, Zheng X, Chen M. A Phase III Multicenter Randomized Clinical Trial of 60 Gy versus 50 Gy Radiation Dose in Concurrent Chemoradiotherapy for Inoperable Esophageal Squamous Cell Carcinoma. Clin Cancer Res. 2022 May 2;28(9):1792-1799. doi: 10.1158/1078-0432.CCR-21-3843.'}, {'pmid': '11870157', 'type': 'BACKGROUND', 'citation': 'Minsky BD, Pajak TF, Ginsberg RJ, Pisansky TM, Martenson J, Komaki R, Okawara G, Rosenthal SA, Kelsen DP. INT 0123 (Radiation Therapy Oncology Group 94-05) phase III trial of combined-modality therapy for esophageal cancer: high-dose versus standard-dose radiation therapy. J Clin Oncol. 2002 Mar 1;20(5):1167-74. doi: 10.1200/JCO.2002.20.5.1167.'}, {'pmid': '10235156', 'type': 'BACKGROUND', 'citation': 'Cooper JS, Guo MD, Herskovic A, Macdonald JS, Martenson JA Jr, Al-Sarraf M, Byhardt R, Russell AH, Beitler JJ, Spencer S, Asbell SO, Graham MV, Leichman LL. Chemoradiotherapy of locally advanced esophageal cancer: long-term follow-up of a prospective randomized trial (RTOG 85-01). Radiation Therapy Oncology Group. JAMA. 1999 May 5;281(17):1623-7. doi: 10.1001/jama.281.17.1623.'}, {'pmid': '33538338', 'type': 'BACKGROUND', 'citation': 'Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.'}]}, 'descriptionModule': {'briefSummary': 'The combination of surufatinib with neoadjuvant chemo-immunotherapy and definitive concurrent chemoradiotherapy represents a promising new therapeutic strategy that may further improve the prognosis of patients with unresectable locally advanced esophageal squamous cell carcinoma (ESCC). Therefore, we propose to conduct a prospective, single-arm, phase II clinical trial to evaluate the efficacy and safety of this regimen in patients with unresectable, locally advanced ESCC.', 'detailedDescription': 'This is a prospective, single-arm, phase II clinical trial designed to evaluate the efficacy and safety of surufatinib in combination with neoadjuvant chemo-immunotherapy and concurrent chemoradiotherapy in patients with unresectable locally advanced esophageal squamous cell carcinoma. Patients will first receive two cycles of neoadjuvant therapy consisting of albumin-bound paclitaxel, cisplatin, toripalimab, and surufatinib. This will be followed by definitive concurrent chemoradiotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or cytologically confirmed diagnosis of esophageal squamous cell carcinoma (ESCC).\n* Locally advanced, unresectable esophageal cancer assessed by endoscopic ultrasound and imaging studies, including esophagography, contrast-enhanced CT scans of the lower neck, chest, and upper abdomen, MRI of the lower neck and chest, whole-body bone scintigraphy, or PET/CT; staged as T2-4, N0-3, M0-1 (M1 limited to supraclavicular lymph node metastasis).\n* Male or female patients aged 18 to 80 years.\n* No prior chemotherapy, radiotherapy, surgery, targeted therapy, or immunotherapy.\n* Expected life expectancy of at least 12 weeks.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Adequate organ and bone marrow function defined as: Forced expiratory volume in one second (FEV1) ≥ 1000 mL; Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L; Platelet count ≥ 100 × 10⁹/L; Hemoglobin ≥ 90 g/L; Creatinine clearance ≥ 50 mL/min calculated by the Cockcroft-Gault formula (Cockcroft and Gault, 1976); Total bilirubin ≤ 1.5 × upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN.\n* Signed and dated informed consent form must be obtained prior to any study-related procedures.\n\nExclusion Criteria:\n\n* Participation in another clinical trial simultaneously, except for observational (non-interventional) studies.\n* Prior use of any targeted therapy.\n* Major surgery within 4 weeks prior to study entry (excluding vascular access procedures).\n* Uncontrolled comorbidities, including but not limited to active or ongoing infections, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina, arrhythmias, active peptic ulcer disease or gastritis, intestinal perforation, bowel obstruction, active bleeding disorders, or psychiatric/social conditions that may impair compliance with study requirements or the ability to provide informed consent.\n* Performance status (PS) score of 2-4.\n* Presence of any of the following organ or bone marrow dysfunctions: Forced expiratory volume in one second (FEV1) \\< 1000 mL; Absolute neutrophil count (ANC) \\< 1.5 × 10⁹/L; Platelet count \\< 100 × 10⁹/L; Hemoglobin \\< 90 g/L; Creatinine clearance \\< 50 mL/min calculated by the Cockcroft-Gault formula (Cockcroft and Gault, 1976); Total bilirubin \\> 1.5 × upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\> 2.5 × ULN.\n* Any condition that may interfere with the assessment of efficacy or safety of surufatinib.'}, 'identificationModule': {'nctId': 'NCT07086469', 'briefTitle': 'Surufatinib in Combination With Neoadjuvant Chemo-immunotherapy and Concurrent Chemoradiotherapy for Patients With Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'A Prospective, Single-arm, Phase II Clinical Trial of Surufatinib in Combination With Neoadjuvant Chemo-immunotherapy and Concurrent Chemoradiotherapy for Patients With Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma', 'orgStudyIdInfo': {'id': 'GASTO-10132'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'The study group', 'description': 'Patients will first receive two cycles of neoadjuvant therapy consisting of albumin-bound paclitaxel, cisplatin, toripalimab, and surufatinib. This will be followed by definitive concurrent radiotherapy combined with albumin-bound paclitaxel, cisplatin, toripalimab, and surufatinib.', 'interventionNames': ['Drug: Neoadjuvant immunochemotherapy', 'Drug: Surufatinib Administration', 'Drug: Concurrent Chemotherapy', 'Radiation: Radiotherapy']}], 'interventions': [{'name': 'Neoadjuvant immunochemotherapy', 'type': 'DRUG', 'description': 'Albumin-bound paclitaxel 260 mg/m² on day 1, cisplatin 25 mg/m² on days 1-3, and toripalimab 240 mg on day 1 of each 3-week cycle (q3w), for a total of 2 cycles.', 'armGroupLabels': ['The study group']}, {'name': 'Surufatinib Administration', 'type': 'DRUG', 'description': 'Surufatinib 200 mg orally once daily (po, qd) on days 1-14, administered concurrently with immunochemotherapy. During radiotherapy, surufatinib will be administered at the start of each radiotherapy phase.', 'armGroupLabels': ['The study group']}, {'name': 'Concurrent Chemotherapy', 'type': 'DRUG', 'description': 'Toripalimab 240 mg on day 1 of each 3-week cycle (q3w), starting one day prior to the initiation of radiotherapy. Weekly administration of albumin-bound paclitaxel 50 mg/m² and cisplatin 25 mg/m² on day 1 during the radiotherapy course.', 'armGroupLabels': ['The study group']}, {'name': 'Radiotherapy', 'type': 'RADIATION', 'description': 'All patients will undergo thoracic intensity-modulated radiotherapy (IMRT), delivered once daily, 5 days per week, at a total prescribed dose of 50 Gy.', 'armGroupLabels': ['The study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510060', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Bo Qiu', 'role': 'CONTACT', 'email': 'qiubo@sysucc.org.cn', 'phone': '02087343031'}], 'facility': 'Sun yat-sen University Cancer Center', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Bo Qiu', 'role': 'CONTACT', 'email': 'qiubo@sysucc.org.cn', 'phone': '+862087343031'}, {'name': 'Hui Liu', 'role': 'CONTACT', 'email': 'liuhui@sysucc.org.cn', 'phone': '02087343031'}], 'overallOfficials': [{'name': 'Hui Liu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sun yat-sen universtiy cancer center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Hui Liu', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}