Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2025-12-25 @ 9:26 PM
Study NCT ID:
NCT04674956
Status:
RECRUITING
Last Update Posted:
2024-04-02
First Post:
2020-12-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Prospective, Randomized, Double-blinded, Multi-center Clinical Trial to Evaluate the Efficiency and Safety of Anti-PD1 Antibody (Camrelizumab) Combined With Paclitaxel(Albumin Bound) and Gemcitabine as First-line Therapy in Patients With Metastatic Pancreatic Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000631724', 'term': 'camrelizumab'}, {'id': 'D013660', 'term': 'Taxes'}, {'id': 'D000093542', 'term': 'Gemcitabine'}], 'ancestors': [{'id': 'D004467', 'term': 'Economics'}, {'id': 'D004472', 'term': 'Health Care Economics and Organizations'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'All participant and investigators are masked.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients are assigned into 2 arms randomly of 1：1.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 401}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-03-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-31', 'studyFirstSubmitDate': '2020-12-15', 'studyFirstSubmitQcDate': '2020-12-15', 'lastUpdatePostDateStruct': {'date': '2024-04-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'CA19-9 in serum', 'timeFrame': '3 years', 'description': 'CA19-9 in serum'}], 'primaryOutcomes': [{'measure': 'Progress free survival', 'timeFrame': '3 years', 'description': 'Time until progress free since randomized.'}], 'secondaryOutcomes': [{'measure': 'Objective Response Rate', 'timeFrame': '3 years', 'description': 'Rate of participants with complete response and partial response.'}, {'measure': 'Disease Control Rate', 'timeFrame': '3 years', 'description': 'Rate of participants with complete response and partial response and stable disease.'}, {'measure': 'Duration of Response', 'timeFrame': '2 years', 'description': 'Time until progress（PD） since first evaluation as CR or PR.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pancreatic Cancer Stage IV', 'Pancreatic Cancer Metastatic']}, 'descriptionModule': {'briefSummary': 'Aim：Evaluate the efficiency and safety of anti-PD1 antibody (Camrelizumab) combined with Paclitaxel(Albumin Bound) and Gemcitabine as first-line therapy in patients with metastatic pancreatic cancer.\n\nDrug information：\n\n* anti-PD1 antibody (Camrelizumab)\n* AG regimens：the standard first-line regimens for metastatic pancreatic cancer.', 'detailedDescription': "CPOG1210-07 is a prospective, randomized, double-blinded, multi-center clinical trial in China aiming to evaluate the efficiency and safety of anti-PD1 antibody (Camrelizumab) combined with Paclitaxel(Albumin Bound) and Gemcitabine versus Paclitaxel(Albumin Bound) and Gemcitabine as first-line therapy in patients with metastatic pancreatic cancer.\n\nThe anti-PD1 antibody(Camrelizumab) is a humanized monoclonal antibody which can specifically bind to PD-1 and block the interaction between PD-1 and its ligand (PD-L1), allowing T cells to recover the immune response against tumors. It is proved to be effective in certain cancers such as ovarian cancers and certification proved by Chinese Food and Drug Administration(CFDA) includes Hodgkin's lymphoma, non-small cell lung cancer, esophageal cancer and liver cancer."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. Aged \\>= 18 years, male or female; 2. Histologically or Cytologically confirmed metastatic pancreatic adenocarcinoma; 3. Patients have never received systematical anti-cancer therapy; 4. Based on Response Evaluation Criteria In Solid Tumors (RECIST1.1), there should be at least one measurable lesion which has never received local treatment like radiotherapy(The lesion located in previous radiotherapy areas can also be selected as target lesions if the progress confirmed.) 5. ECOG:0-1; 6. Expected survival\\>=12 weeks; 7. Essential organs function must meet the following criteria (Any blood products, growth factor, leucocyte promoting drugs, platelet promoting drugs, drugs for anemia are not allowed in 14 days before the first use of the experimental medication):\n\n 1. Absolute neutrophil count(ANC) \\>= 1.5x10\\^9/L\n 2. Platelet \\>= 85x10\\^9/L\n 3. Hemoglobin \\>= 90g/L\n 4. Serum Albumin \\>= 30g/L\n 5. Total bilirubin \\<= 2.0 ULN (Biliary obstructive patients after biliary drainage \\<= 2.5 ULN), AST and ALT \\<= 3.0 ULN (patients with liver metastasis \\<= 5 ULN);\n 6. Creatinine clearance rate \\>60 mL/min;\n 7. Activated Partial Thromboplastin Time and International Standardized Ratio \\<= 1.5 ULN (Patients using stable dose of anticoagulant therapy such as low molecular weight heparin or warfarin and INR is within the expected range of anticoagulants can be selected.)\n\nExclusion Criteria:\n\n* 1\\. Patients with central nervous system metastasis. 2. Patients only have local advanced diseases. 3. Patients have uncontrolled pleural, pericardial or abdominal effusion requiring drainage.\n\n 4\\. Patients with history of allergy to monoclonal antibodies, any component of SHR-1210, paclitaxel(Albumin Bound) and Gemcitabine.\n\n 5\\. Patients have ever received anti PD-1 or anti PD-L1 therapy in the past. 6. Patients have accepted any experimental medication.within 4 weeks before the first dose of our experimental medication administration.\n\n 7\\. Patients are enrolled in another clinical trial except for observational clinical trial (Non-interventional) or the follow-up of the interventional clinical trial. 8. Patients accepted the last dose of anti-cancer therapy (including radiotherapy) within 4 weeks before the first dose of experimental medication administration.\n\n 9\\. Patients who need corticosteroid or other immunosuppressive agents. 10. Patients who ever received anti-cancer vaccine or have received live vaccine within 4 weeks before the first dose of administration.\n\n 11\\. Patients who have received major surgery within 4 weeks before the first dose of administration.\n\n 12\\. Patients with active autoimmune diseases, history of autoimmune diseases. 13. History of immunodeficiency, including HIV positive test, or other acquired, congenital immunodeficiency disorders, or history of organ transplantation and allogeneic bone marrow transplantation.\n\n 14\\. Patients with uncontrolled cardiovascular clinical symptoms or diseases. 15. Severe infections occurred within 4 weeks before the first administration. 16. History of interstitial lung disease and non- infectious pneumonia. 17. Patients with active pulmonary tuberculosis (APTB) infection confirmed by medical history or CT examination.\n\n 18\\. Patients with active hepatitis B or hepatitis C. 19. Patients with any other malignant tumors diagnosed within 5 years before the first administration.\n\n 20\\. Pregnant or lactating women. 21. According to the researchers, participants have other factors that may force them to end up the study.'}, 'identificationModule': {'nctId': 'NCT04674956', 'briefTitle': 'A Prospective, Randomized, Double-blinded, Multi-center Clinical Trial to Evaluate the Efficiency and Safety of Anti-PD1 Antibody (Camrelizumab) Combined With Paclitaxel(Albumin Bound) and Gemcitabine as First-line Therapy in Patients With Metastatic Pancreatic Cancer', 'organization': {'class': 'OTHER', 'fullName': 'RenJi Hospital'}, 'officialTitle': 'A Prospective, Randomized, Double-blinded, Multi-center Clinical Trial to Evaluate the Efficiency and Safety of Anti-PD1 Antibody (Camrelizumab) Combined With Paclitaxel(Albumin Bound) and Gemcitabine Versus Paclitaxel(Albumin Bound) and Gemcitabine as First-line Therapy in Patients With Metastatic Pancreatic Cancer', 'orgStudyIdInfo': {'id': 'CPOG1210-07'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment arm', 'description': 'Regimens：anti-PD1 antibody and AG regimens.', 'interventionNames': ['Drug: Camrelizumab', 'Drug: Paclitaxel(Albumin Bound) and Gemcitabine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control arm', 'description': 'Regimens：Placebo and AG regimens.', 'interventionNames': ['Drug: Paclitaxel(Albumin Bound) and Gemcitabine', 'Drug: Placebo']}], 'interventions': [{'name': 'Camrelizumab', 'type': 'DRUG', 'description': 'PD-1 antibody（Camrelizumab）, 200mg, D1; every 21 days as a cycle.', 'armGroupLabels': ['Treatment arm']}, {'name': 'Paclitaxel(Albumin Bound) and Gemcitabine', 'type': 'DRUG', 'description': 'Paclitaxel(Albumin Bound), 125 mg/m2D18; Gemcitabine, 1000mg/m2D1, 8;every 21 days as a cycle.', 'armGroupLabels': ['Control arm', 'Treatment arm']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo, 200mg, D1; every 21 days as a cycle.', 'armGroupLabels': ['Control arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200025', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jun Zhang, Dr', 'role': 'CONTACT', 'email': 'junzhang10977@sjtu.edu.cn', 'phone': '+86-13512118830'}], 'facility': 'Ruijin hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Weijian Guo, Dr', 'role': 'CONTACT', 'email': 'guoweijian1@sohu.com', 'phone': '+86-18021021985'}], 'facility': 'Shanghai Cancer Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yuhong Zhou, Dr', 'role': 'CONTACT', 'email': 'zhou.yuhong@zs-hospital.sh.cn', 'phone': '+86-13918286810'}], 'facility': 'Zhongshan Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200080', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qi Li, Dr', 'role': 'CONTACT', 'email': 'leeqi@sjtu.edu.cn', 'phone': '+86-13611956117'}], 'facility': 'Shanghai General Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200127', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Liwei Wang, Dr', 'role': 'CONTACT', 'email': 'lwwang2013@163.com', 'phone': '+86 16621086648'}], 'facility': 'Renji hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200433', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xianbao Zhan, Dr', 'role': 'CONTACT', 'email': 'zhanxianbao@csco.org.cn', 'phone': '+86-13764528043'}], 'facility': 'Changhai Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Liwei Wang, Doctor', 'role': 'CONTACT', 'email': 'lwwang@163.com', 'phone': '+86 16621086648'}, {'name': 'Tiebo Mao, Doctor', 'role': 'CONTACT', 'email': 'maotb4@163.com', 'phone': '+86 16621086648'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Share within six months after the trial complete. IPD: Study protocol，statistical analysis plan，informed consent form and clinical study report.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RenJi Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of department of oncology', 'investigatorFullName': 'liwei wang', 'investigatorAffiliation': 'RenJi Hospital'}}}}