Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2025-12-29 @ 1:13 AM
Study NCT ID:
NCT06339060
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-03-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Organ Preservation Strategies After Chemoradiotherapy Combined With Immunotherapy for Esophageal Cancer (PALACE3).
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004938', 'term': 'Esophageal Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Randomize patients who meet the inclusion criteria Grouping, randomly assigned to the experimental group in a 1:1 ratio (organ preservation strategy after neoadjuvant chemotherapy combined with immunotherapy) And the control group (limited time for esophageal cancer radical surgery after neoadjuvant radiotherapy and chemotherapy)'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 356}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2028-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-30', 'studyFirstSubmitDate': '2024-03-16', 'studyFirstSubmitQcDate': '2024-03-29', 'lastUpdatePostDateStruct': {'date': '2024-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '3-year overall survival rate', 'timeFrame': 'From date of randomization until the date of death from any cause，up to 5 years', 'description': 'The proportion of patients who survived within 3 years from randomization'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chemoradiotherapy', 'Immunotherapy', 'Organ preservation', 'Active surveillance'], 'conditions': ['Esophageal Cancer']}, 'descriptionModule': {'briefSummary': 'Patients with locally advanced esophageal squamous cell carcinoma will randomly assigned to receive neoadjuvant chemo-radiotherapy combined with immunotherapy post organ preservation strategy (experimental group) or neoadjuvant chemo-radiotherapy followed by surgery (control group).\n\nThe 3-year overall survival rate is the primary outcome.', 'detailedDescription': 'The investigators will conduct the open, multicenter, prospective, randomized controlled clinical study(PALACE3). Patients with locally advanced esophageal squamous cell carcinoma will randomly assigned to either receive neoadjuvant synchronous radiotherapy and chemotherapy combined with immunotherapy followed by organ preservation strategy (experimental group, Arm1) or neoadjuvant concurrent radiotherapy and chemotherapy followed by radical surgery (control group,Arm 2). Collect relevant data on preoperative treatment, re examination after neoadjuvant therapy, perioperative and long-term follow-up of patients, and evaluate the clinical treatment effects (cCR rate), surgical pathological results (pCR rate, R0 resection rate, tumor regression grade, lymph node positivity rate), neoadjuvant therapy and perioperative complications, long-term oncological effects (total survival, disease-free survival), and quality of life of the two treatment plans through statistical analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* A patient will be eligible for inclusion in this study only if ALL of the following criteria apply:\n\n * Histologically confirmed cT2-T4a,N0-N+,M0 resectable esophageal squamous cell carcinoma.\n * Eastern Cooperative Oncology Group (ECOG) performance status 0-1\n * Patients approve and sign the informed consent\n\nExclusion Criteria:\n\n* Patients with active autoimmune disease or history of autoimmune disease.\n* Patients who have a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications.\n* Subjects with a history of symptomatic interstitial lung disease.\n* History of allergy to study drug components.\n* Women must not be pregnant or breast-feeding.\n* Men with female partners (WOCBP) that are not willing to use contraception.\n* Patient has received prior chemotherapy, radiotherapy, target therapy and immune therapy for this malignancy or for any other past malignancy.\n* medical conditions that, in the Investigator's opinion, will make the administration of study drug hazardous or obscure the interpretation of toxicity or adverse events"}, 'identificationModule': {'nctId': 'NCT06339060', 'acronym': 'PALACE3', 'briefTitle': 'An Organ Preservation Strategies After Chemoradiotherapy Combined With Immunotherapy for Esophageal Cancer (PALACE3).', 'organization': {'class': 'OTHER', 'fullName': 'Ruijin Hospital'}, 'officialTitle': 'An Organ Preservation Strategies After Chemoradiotherapy Combined With Immunotherapy for Esophageal Cancer vs Cross Therapy.', 'orgStudyIdInfo': {'id': 'RTS-022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm1 Organ preservation', 'description': 'A: Camrelizumab 200mg IV on days 1 and 22 B: Carboplatin (AUC=2) IV and Paclitaxel-albumin (50mg/m²) IV on day 1,8,15,22,29.\n\nC: Radiotherapy will start on day 1 of chemotherapy. A total of 41.4 Gy, 23 fractions of 1.8 Gy, 5 fractions a week.\n\nA+B+C=neoadjuvant therapy Patients will undergo clinical response evaluations (CREs) after neoadjuvant therapy(A+B+C）, If cancer is detected, surgery will be performed. Patients with clinical complete response （cCR） are eligible for active surveillance where regular CREs are performed to detect regrowth of cancer.Postoperative adjuvant therapy will follow the NCCN guideline.', 'interventionNames': ['Combination Product: Experimental: Arm 1 Organ preservation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 2 Surgery', 'description': 'A: Camrelizumab 200mg IV on days 1 and 22 B: Carboplatin (AUC=2) IV and Paclitaxel-albumin (50mg/m²) IV on day 1,8,15,22,29.\n\nC: Radiotherapy will start on day 1 of chemotherapy. A total of 41.4 Gy, 23 fractions of 1.8 Gy, 5 fractions a week.\n\nOesophagectomy will be offered to patients without contraindication.Postoperative adjuvant therapy will follow the NCCN guideline.', 'interventionNames': ['Combination Product: Active Comparator: Arm 2 Surgery']}], 'interventions': [{'name': 'Experimental: Arm 1 Organ preservation', 'type': 'COMBINATION_PRODUCT', 'description': 'Arm 1 patients will undergo clinical response evaluations (CREs) after neoadjuvant therapy(A+B+C）, If cancer is detected, surgery will be performed. Patients with clinical complete response （cCR） are eligible for active surveillance where regular CREs are performed to detect regrowth of cancer.Postoperative adjuvant therapy will follow the NCCN guideline.\n\nA: Camrelizumab 200mg IV on days 1 and 22 B: Carboplatin (AUC=2) IV and Paclitaxel-albumin (50mg/m²) IV on day 1,8,15,22,29.\n\nC: Radiotherapy will start on day 1 of chemotherapy. A total of 41.4 Gy, 23 fractions of 1.8 Gy, 5 fractions a week.\n\nA+B+C=Neoadjuvant therapy', 'armGroupLabels': ['Arm1 Organ preservation']}, {'name': 'Active Comparator: Arm 2 Surgery', 'type': 'COMBINATION_PRODUCT', 'description': 'Arm 2 patients will undergo surgery after neoadjuvant therapy(B+C）.Postoperative adjuvant therapy will follow the NCCN guideline.\n\nB: Carboplatin (AUC=2) IV and Paclitaxel-albumin (50mg/m²) IV on day 1,8,15,22,29.\n\nC: Radiotherapy will start on day 1 of chemotherapy. A total of 41.4 Gy, 23 fractions of 1.8 Gy, 5 fractions a week.', 'armGroupLabels': ['Arm 2 Surgery']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chengqiang LI, MD/PHD', 'role': 'CONTACT', 'phone': '19121652450'}, {'name': 'Yuqin Cao, MD/PHD', 'role': 'CONTACT'}], 'facility': 'Ruijin hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Hecheng Li', 'role': 'CONTACT', 'email': 'lihecheng2000@hotmail.com', 'phone': '19121652450'}, {'name': 'Chengqiang Li', 'role': 'CONTACT', 'email': 'lcq12305@rjh.com.cn', 'phone': '13524282905'}], 'overallOfficials': [{'name': 'Hecheng Li, MD/PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ruijin Hospital Shanghaijiaotong University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ruijin Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof', 'investigatorFullName': 'Hecheng Li M.D., Ph.D', 'investigatorAffiliation': 'Ruijin Hospital'}}}}