Last updated: March 31, 2024
Sponsor: RenJi Hospital
Overall Status: Active - Recruiting
Phase
3
Condition
Digestive System Neoplasms
Treatment
Camrelizumab
Placebo
Paclitaxel(Albumin Bound) and Gemcitabine
Clinical Study ID
NCT04674956
CPOG1210-07
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Aged >= 18 years, male or female; 2. Histologically or Cytologically confirmedmetastatic pancreatic adenocarcinoma; 3. Patients have never received systematicalanti-cancer therapy; 4. Based on Response Evaluation Criteria In Solid Tumors (RECIST1.1), there should be at least one measurable lesion which has never receivedlocal treatment like radiotherapy(The lesion located in previous radiotherapy areascan 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 followingcriteria (Any blood products, growth factor, leucocyte promoting drugs, plateletpromoting drugs, drugs for anemia are not allowed in 14 days before the first use ofthe experimental medication):
- Absolute neutrophil count(ANC) >= 1.5x10^9/L
- Platelet >= 85x10^9/L
- Hemoglobin >= 90g/L
- Serum Albumin >= 30g/L
- 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);
- Creatinine clearance rate >60 mL/min;
- Activated Partial Thromboplastin Time and International Standardized Ratio <= 1.5ULN (Patients using stable dose of anticoagulant therapy such as low molecularweight heparin or warfarin and INR is within the expected range of anticoagulantscan be selected.)
Exclusion
Exclusion Criteria:
- Patients with central nervous system metastasis. 2. Patients only have localadvanced diseases. 3. Patients have uncontrolled pleural, pericardial or abdominaleffusion requiring drainage.
- Patients with history of allergy to monoclonal antibodies, any component ofSHR-1210, paclitaxel(Albumin Bound) and Gemcitabine.
- 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 firstdose of our experimental medication administration.
- Patients are enrolled in another clinical trial except for observational clinicaltrial (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.
- Patients who need corticosteroid or other immunosuppressive agents. 10. Patientswho ever received anti-cancer vaccine or have received live vaccine within 4 weeksbefore the first dose of administration.
- Patients who have received major surgery within 4 weeks before the first dose ofadministration.
- 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 andallogeneic bone marrow transplantation.
- Patients with uncontrolled cardiovascular clinical symptoms or diseases. 15.Severe infections occurred within 4 weeks before the first administration. 16. Historyof interstitial lung disease and non- infectious pneumonia. 17. Patients with activepulmonary tuberculosis (APTB) infection confirmed by medical history or CTexamination.
- Patients with active hepatitis B or hepatitis C. 19. Patients with any othermalignant tumors diagnosed within 5 years before the first administration.
- Pregnant or lactating women. 21. According to the researchers, participants haveother factors that may force them to end up the study.
Study Design
Total Participants: 401
Treatment Group(s): 3
Primary Treatment: Camrelizumab
Phase: 3
Study Start date:
March 04, 2021
Estimated Completion Date:
December 31, 2025
Study Description
Connect with a study center
Changhai Hospital
Shanghai, Shanghai 200433
ChinaActive - Recruiting
Renji hospital
Shanghai, Shanghai 200127
ChinaActive - Recruiting
Ruijin hospital
Shanghai, Shanghai 200025
ChinaActive - Recruiting
Shanghai Cancer Center
Shanghai, Shanghai 200032
ChinaActive - Recruiting
Shanghai General Hospital
Shanghai, Shanghai 200080
ChinaActive - Recruiting
Zhongshan Hospital
Shanghai, Shanghai 200032
ChinaActive - Recruiting
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