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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04674956
Other study ID # CPOG1210-07
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date March 4, 2021
Est. completion date December 31, 2025

Study information

Verified date March 2024
Source RenJi Hospital
Contact Liwei Wang, Doctor
Phone +86 16621086648
Email lwwang@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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. Drug information: - anti-PD1 antibody (Camrelizumab) - AG regimens:the standard first-line regimens for metastatic pancreatic cancer.


Description:

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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 401
Est. completion date December 31, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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): 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: - 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. 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.

Study Design


Intervention

Drug:
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.

Locations

Country Name City State
China Changhai Hospital Shanghai Shanghai
China Renji hospital Shanghai Shanghai
China Ruijin hospital Shanghai Shanghai
China Shanghai Cancer Center Shanghai Shanghai
China Shanghai General Hospital Shanghai Shanghai
China Zhongshan Hospital Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other CA19-9 in serum CA19-9 in serum 3 years
Primary Progress free survival Time until progress free since randomized. 3 years
Secondary Objective Response Rate Rate of participants with complete response and partial response. 3 years
Secondary Disease Control Rate Rate of participants with complete response and partial response and stable disease. 3 years
Secondary Duration of Response Time until progress(PD) since first evaluation as CR or PR. 2 years
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