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

Who is this study for? Patients with Metastatic Pancreatic Cancer
What treatments are being studied? Paclitaxel (Albumin Bound) and Gemcitabine
Status: Recruiting
Location: See all (6) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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):

‣ 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 \<= 1.5 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.)

Locations
Other Locations
China
Changhai Hospital
RECRUITING
Shanghai
Renji hospital
RECRUITING
Shanghai
Ruijin hospital
RECRUITING
Shanghai
Shanghai Cancer Center
RECRUITING
Shanghai
Shanghai General Hospital
RECRUITING
Shanghai
Zhongshan Hospital
RECRUITING
Shanghai
Contact Information
Primary
Liwei Wang, Doctor
lwwang@163.com
+86 16621086648
Backup
Tiebo Mao, Doctor
maotb4@163.com
+86 16621086648
Time Frame
Start Date: 2021-03-04
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 401
Treatments
Experimental: Treatment arm
Regimens:anti-PD1 antibody and AG regimens.
Placebo_comparator: Control arm
Regimens:Placebo and AG regimens.
Related Therapeutic Areas
Sponsors
Leads: RenJi Hospital

This content was sourced from clinicaltrials.gov

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