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
NCT ID: NCT04674956
Last Updated: 2024-04-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
401 participants
INTERVENTIONAL
2021-03-04
2025-12-31
Brief Summary
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Drug information：
* anti-PD1 antibody (Camrelizumab)
* AG regimens：the standard first-line regimens for metastatic pancreatic cancer.
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Detailed Description
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The 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Treatment arm
Regimens：anti-PD1 antibody and AG regimens.
Camrelizumab
PD-1 antibody（Camrelizumab）, 200mg, D1; every 21 days as a cycle.
Paclitaxel(Albumin Bound) and Gemcitabine
Paclitaxel(Albumin Bound), 125 mg/m2D18; Gemcitabine, 1000mg/m2D1, 8;every 21 days as a cycle.
Control arm
Regimens：Placebo and AG regimens.
Paclitaxel(Albumin Bound) and Gemcitabine
Paclitaxel(Albumin Bound), 125 mg/m2D18; Gemcitabine, 1000mg/m2D1, 8;every 21 days as a cycle.
Placebo
Placebo, 200mg, D1; every 21 days as a cycle.
Interventions
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Camrelizumab
PD-1 antibody（Camrelizumab）, 200mg, D1; every 21 days as a cycle.
Paclitaxel(Albumin Bound) and Gemcitabine
Paclitaxel(Albumin Bound), 125 mg/m2D18; Gemcitabine, 1000mg/m2D1, 8;every 21 days as a cycle.
Placebo
Placebo, 200mg, D1; every 21 days as a cycle.
Eligibility Criteria
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Inclusion Criteria
1. Absolute neutrophil count(ANC) \>= 1.5x10\^9/L
2. Platelet \>= 85x10\^9/L
3. Hemoglobin \>= 90g/L
4. Serum Albumin \>= 30g/L
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);
6. Creatinine clearance rate \>60 mL/min;
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.)
Exclusion Criteria
4\. Patients with history of allergy to monoclonal antibodies, any component of SHR-1210, paclitaxel(Albumin Bound) and Gemcitabine.
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.
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.
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.
11\. Patients who have received major surgery within 4 weeks before the first dose of administration.
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.
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.
18\. Patients with active hepatitis B or hepatitis C. 19. Patients with any other malignant tumors diagnosed within 5 years before the first administration.
20\. Pregnant or lactating women. 21. According to the researchers, participants have other factors that may force them to end up the study.
18 Years
ALL
No
Sponsors
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RenJi Hospital
OTHER
Responsible Party
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liwei wang
Director of department of oncology
Locations
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Ruijin hospital
Shanghai, Shanghai Municipality, China
Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Zhongshan Hospital
Shanghai, Shanghai Municipality, China
Shanghai General Hospital
Shanghai, Shanghai Municipality, China
Renji hospital
Shanghai, Shanghai Municipality, China
Changhai Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CPOG1210-07
Identifier Type: -
Identifier Source: org_study_id
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