Evaluating a new treatment for metastatic pancreatic cancer

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

This study is testing a new combination treatment for metastatic pancreatic cancer to see if it works better than the standard treatment.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 401 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: RenJi Hospital (Academic / other)
• Drugs / interventions: Camrelizumab
• Locations: 6 sites (Shanghai, Shanghai and 5 other locations)
• Trial ID: NCT04674956 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the safety and effectiveness of the anti-PD1 antibody Camrelizumab when combined with Paclitaxel (Albumin Bound) and Gemcitabine as a first-line treatment for patients with metastatic pancreatic cancer. It is a prospective, randomized, double-blinded, multi-center trial conducted in China. Participants will be compared against a control group receiving standard treatment with Paclitaxel and Gemcitabine alone. The study will include patients who have not previously received systemic anti-cancer therapy and have measurable lesions.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed metastatic pancreatic adenocarcinoma who have not received prior systemic anti-cancer therapy.

Not a fit: Patients with prior systemic anti-cancer therapy or those with severe organ dysfunction may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with advanced pancreatic cancer.

How similar studies have performed: While the use of anti-PD1 antibodies has shown promise in other cancers, this specific combination for pancreatic cancer is relatively novel and has not been extensively tested.

Eligibility criteria

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.

Where this trial is running

Shanghai, Shanghai and 5 other locations

• Ruijin hospital — Shanghai, Shanghai, China (Recruiting)
• Shanghai Cancer Center — Shanghai, Shanghai, China (Recruiting)
• Zhongshan Hospital — Shanghai, Shanghai, China (Recruiting)
• Shanghai General Hospital — Shanghai, Shanghai, China (Recruiting)
• Renji hospital — Shanghai, Shanghai, China (Recruiting)
• Changhai Hospital — Shanghai, Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Liwei Wang, Doctor

Conditions Pancreatic Cancer Stage IV; Pancreatic Cancer Metastatic