Clinical trial NCT04674956: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Pancreatic Cancer Stage IV
Pancreatic Cancer Metastatic
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2020-12-19
Enrollment: 401
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients are assigned into 2 arms randomly of 1：1.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

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.

Primary outcomes:
measure: Progress free survival
timeFrame: 3 years
Secondary outcomes:
measure: Objective Response Rate
timeFrame: 3 years
measure: Disease Control Rate
timeFrame: 3 years
measure: Duration of Response
timeFrame: 2 years
Other outcomes:
measure: CA19-9 in serum
timeFrame: 3 years
Locations:
city: Shanghai
country: China
facility: Ruijin hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Cancer Center
state: Shanghai
city: Shanghai
country: China
facility: Zhongshan Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai General Hospital
state: Shanghai
city: Shanghai
country: China
facility: Renji hospital
state: Shanghai
city: Shanghai
country: China
facility: Changhai Hospital
state: Shanghai
Study officials:
References: