Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2026-01-02 @ 1:04 AM
Study NCT ID:
NCT06454435
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-12
First Post:
2024-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Conversion Therapy of Sintilimab in Combination With Fruquintinib and Chemotherapy Versus Sintilimab and Chemotherpay in Stage IV Gastric Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000632826', 'term': 'sintilimab'}, {'id': 'C079198', 'term': 'S 1 (combination)'}, {'id': 'C520255', 'term': '130-nm albumin-bound paclitaxel'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 158}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-06', 'studyFirstSubmitDate': '2024-06-06', 'studyFirstSubmitQcDate': '2024-06-06', 'lastUpdatePostDateStruct': {'date': '2024-06-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'R0-surgery conversion rate', 'timeFrame': 'about 3 years', 'description': 'The proportion of patients who underwent R0 surgery among all efficacy evaluable patients.'}], 'secondaryOutcomes': [{'measure': 'Pathological complete response (pCR)', 'timeFrame': 'about 3 years', 'description': 'The proportion of patients with a pathological complete response (ypT0\\&N0) at the time of definitive surgery among all patients who underwent conversation surgery.'}, {'measure': 'Major pathological response rate (MPR)', 'timeFrame': 'about 3 years', 'description': 'The proportion of patients with a major pathological response (≤10% residual viable tumor) at the time of definitive surgery among all patients who underwent conversation surgery.'}, {'measure': 'Rate of downstaging', 'timeFrame': 'about 3 years', 'description': 'To determine the rate of ypT0 and ypN0, and downstaging ratio of preoperative imaging clinical stage compared with baseline.'}, {'measure': 'Objective response rate (ORR)', 'timeFrame': 'about 3 years', 'description': 'The proportion of patients who achieved complete response (CR) or partial response(PR) per RECIST v1.1.'}, {'measure': 'Disease control rate (DCR)', 'timeFrame': 'about 3 years', 'description': 'The proportion of patients who achieved CR, PR or stable disease(SD) per RECIST v1.1.'}, {'measure': 'Overall survival (OS)', 'timeFrame': 'about 3 years', 'description': 'The time from the initial date of conversation therapy to the date of death due to any cause.'}, {'measure': 'Progression-free survival (PFS)', 'timeFrame': 'about 3 years', 'description': 'The time from the initial date of conversation therapy to the date of first documentation of disease progression or death due to any cause, whichever occurs first.'}, {'measure': 'Adverse event (AEs)', 'timeFrame': 'about 3 years', 'description': 'Toxicity according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Incidence and grade of surgery-related complications will also be as assessed.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastric Cancer', 'Gastric Adenocarcinoma', 'Gastroesophageal Junction Adenocarcinoma']}, 'descriptionModule': {'briefSummary': 'This is a multicenter, randomized, open-label, phase 2 clinical study aiming to evaluate the feasibility and efficacy of sintilimab (PD-1 inhibitor) in combination of fruquintinib and chemotherapy (S-1 plus nab-paclitaxel) versus sintilimab and chemotherapy as conversion therapy in patients with stage IV gastric cancer in China.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Histologically confirmed gastric/gastroesophageal junction adenocarcinoma through gastroscopy.\n* Ages: 18-70 Years (concluding 18 and 70 Years)\n* Life expectancy ≥3 months.\n* Treatment-naive Stage IV (clinical staging, AJCC 8th) unresectable patients, no prior antitumor therapy (including radiation, chemotherapy, targeted therapy or immunotherapy, etc.).\n* The Eastern Cooperative Oncology Group Performance status (ECOG PS) of 0-1.\n* Preoperative examinations using CT, MRI, PET-CT, etc., indicating only one unresectable factor OR peritoneal metastasis with another unresectable factor, such as:\n\n 1. N3 lymph node metastasis, mainly referring to group 16 lymph node metastasis.\n 2. Extensive or bulky lymph nodes (D2)\n 3. Locally advanced T4b.\n 4. Hepatic metastases (H1): ≤5 lesions with a total diameter ≤8cm.\n 5. Peritoneal metastasis (CY1, P1).\n 6. Ovarian metastasis (Krukenberg tumor).\n* Physically fit for major abdominal surgery.\n* Adequate organ and marrow function, defined as:\n\n 1. Hematological status: Absolute neutrophil count (ANC) ≥1.5×10\\^9/L; Platelet count (PLT) ≥100×10\\^9/L; Hemoglobin (HGB) ≥9.0 g/dL.\n 2. Liver function: For patients without liver metastasis, serum total bilirubin (TBIL) ≤1.5× upper limit of normal (ULN); ALT and AST ≤2.5×ULN. For patients with liver metastasis: TBIL ≤1.5×ULN; ALT and AST ≤5×ULN.\n 3. Renal function: Creatinine clearance (Ccr) ≥50 mL/min (calculated using the Cockcroft/Gault formula).\n* Adequate coagulation function, defined as International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5 times ULN.\n* Voluntary participation and signed informed consent with expected good compliance and follow-up.\n* Not involved in other clinical trials.\n* Willing to provide blood and histological samples.\n* No serious conditions affecting anesthesia, or surgery.\n* No hematologic disorders affecting postoperative hemoglobin levels.\n\nExclusion Criteria:\n\n* Has distal metastases other than oligometastases as defined in the inclusion criteria, such as pulmonary metastases, brain metastases, bone metastases, etc.\n* HER-2 positive patients or willing to receive Trastuzumab.\n* Endoscopic signs of active bleeding from the lesion.\n* Patients with moderate/large volume of ascites.\n* Near-obstruction at the cardia or pylorus affecting feeding and gastric emptying or difficulty swallowing tablets.\n* Concurrently suffering from other serious illnesses that are difficult to control (Severe uncontrolled recurrent infections, atrial fibrillation, angina pectoris, cardiac insufficiency, ejection fraction measurement under 50%, uncontrolled hypertension, renal insufficiency, symptomatic peripheral neuropathy, and NCI classification \\>II)\n* Has already on other medications prior to enrollment or could not be assured of compliance after enrollment.\n* Allergy to any drugs in the regimen.\n* Women who are pregnant or breastfeeding and have childbearing potential but are not taking adequate contraceptive measures.\n* Organ transplant recipients requiring immunosuppression.\n* Patients without decision-making capacity or with psychiatric disorders.\n* Systemic treatment with Chinese herbal anti-tumor or immunomodulatory drugs (including thymosin, interferons, interleukins) within 2 weeks before the first dose.\n* Use of immunosuppressive drugs within 4 weeks before the first study treatment, excluding local steroids or physiological doses of systemic steroids.\n* Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study treatment.\n* Has a diagnosis of autoimmune disease within the previous 2 years (Patients with vitiligo, psoriasis, alopecia areata, or Graves' disease who do not require systemic therapy within the last 2 years, hypothyroidism requiring only thyroid hormone replacement therapy, and type I diabetes mellitus requiring only insulin replacement therapy are eligible for enrollment).\n* Known history of primary immunodeficiency.\n* Known to have active tuberculosis.\n* Has history of human immunodeficiency virus (HIV) infection (i.e., HIV antibody . positive); untreated acute or chronic active hepatitis B or hepatitis C infection. Patients receiving antiretroviral therapy are eligible for enrollment on an individual basis as determined by the physician with monitoring of viral copy number.\n* Urinalysis indicating urine protein ≥2+ and 24-hour urine protein quantification \\>1.0g."}, 'identificationModule': {'nctId': 'NCT06454435', 'briefTitle': 'Conversion Therapy of Sintilimab in Combination With Fruquintinib and Chemotherapy Versus Sintilimab and Chemotherpay in Stage IV Gastric Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Tianjin Medical University Cancer Institute and Hospital'}, 'officialTitle': 'Sintilimab Combined With Fruquintinib and Chemotherapy Versus Sintilimab and Chemotherapy for Conversion Therapy in Unresectable Stage IV Gastric Cancer: a National Multicenter Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'E20231573'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sintilimab + Fruquinitinib + S-1 plus nab-paclitaxel', 'interventionNames': ['Drug: Sintilimab + Fruquinitinib + S-1 plus nab-paclitaxel']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sintilimab + S-1 plus nab-paclitaxel', 'interventionNames': ['Drug: Sintilimab + S-1 plus nab-paclitaxel']}], 'interventions': [{'name': 'Sintilimab + Fruquinitinib + S-1 plus nab-paclitaxel', 'type': 'DRUG', 'description': 'Drug: Sintilimab Sintilimab 200mg, D1, IV, Q3W 4-8 cycles Drug: Fruquintinib Fruquinitinib 4mg/d, QD, PO, D1-D14, Q3W 4-8 cycles Drug: S-1 BSA\\<1.25 m2, 40mg twice/day; BSA 1.25-1.5m2, 50mg twice/day; BSA≥1.5 m2, 60mg twice/day, po, D1-D14, Q3W 4-8 cycles Drug: Nab-paclitaxel\n\n* without peritoneal metastases: 260 mg/m2, IV, D1 for 3h, Q3W 4-8 cycles;\n* with peritoneal metastases: 80mg/m2 IP, plus 180mg/m2, IV, D1, Q3W 4-8 cycles.', 'armGroupLabels': ['Sintilimab + Fruquinitinib + S-1 plus nab-paclitaxel']}, {'name': 'Sintilimab + S-1 plus nab-paclitaxel', 'type': 'DRUG', 'description': 'Drug: Sintilimab Sintilimab 200mg, D1, IV, Q3W 4-8 cycles Drug: S-1 BSA\\<1.25 m2, 40mg twice/day; BSA 1.25-1.5m2, 50mg twice/day; BSA≥1.5 m2, 60mg twice/day, po, D1-D14, Q3W 4-8 cycles Drug: Nab-paclitaxel\n\n* without peritoneal metastases: 260 mg/m2, IV, D1 for 3h, Q3W 4-8 cycles;\n* with peritoneal metastases: 80mg/m2 IP, plus 180mg/m2, IV, D1, Q3W 4-8 cycles.', 'armGroupLabels': ['Sintilimab + S-1 plus nab-paclitaxel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210000', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'country': 'China', 'contacts': [{'name': 'Han Liang, MD', 'role': 'CONTACT', 'email': 'tjlianghan@126.com', 'phone': '18622221082'}], 'facility': 'Tianjin Medical University Cancer Institute and Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'centralContacts': [{'name': 'Han Liang, MD', 'role': 'CONTACT', 'email': 'tjlianghan@126.com', 'phone': '18622221082'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tianjin Medical University Cancer Institute and Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}