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

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

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

    1. 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):
  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 <= 1.5ULN (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:

    1. Patients with central nervous system metastasis. 2. Patients only have localadvanced diseases. 3. Patients have uncontrolled pleural, pericardial or abdominaleffusion requiring drainage.
  1. Patients with history of allergy to monoclonal antibodies, any component ofSHR-1210, paclitaxel(Albumin Bound) and Gemcitabine.
  2. 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.
  3. 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.
  4. 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.
  5. Patients who have received major surgery within 4 weeks before the first dose ofadministration.
  6. 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.
  7. 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.
  8. Patients with active hepatitis B or hepatitis C. 19. Patients with any othermalignant tumors diagnosed within 5 years before the first administration.
  9. 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

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.

Connect with a study center

  • Changhai Hospital

    Shanghai, Shanghai 200433
    China

    Active - Recruiting

  • Renji hospital

    Shanghai, Shanghai 200127
    China

    Active - Recruiting

  • Ruijin hospital

    Shanghai, Shanghai 200025
    China

    Active - Recruiting

  • Shanghai Cancer Center

    Shanghai, Shanghai 200032
    China

    Active - Recruiting

  • Shanghai General Hospital

    Shanghai, Shanghai 200080
    China

    Active - Recruiting

  • Zhongshan Hospital

    Shanghai, Shanghai 200032
    China

    Active - Recruiting

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