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

NCT04674956 | Recruiting Phase 3

• 1 other identifier: CPOG1210-07
• Study Type: interventional
• Target: 401
• Locations: 1 country
• Sites: 6

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.

Conditions

Pancreatic Cancer Stage IV; Pancreatic Cancer Metastatic

Outcome Measures

Primary Outcomes (1)

• Progress free survival

  Time until progress free since randomized.

  3 years

Secondary Outcomes (3)

• Objective Response Rate

  3 years

• Disease Control Rate

  3 years

• Duration of Response

  2 years

Other Outcomes (1)

• CA19-9 in serum

  3 years

Study Arms (2)

Treatment arm

EXPERIMENTAL

Regimens：anti-PD1 antibody and AG regimens.

Drug: Camrelizumab; Drug: Paclitaxel(Albumin Bound) and Gemcitabine

Control arm

PLACEBO COMPARATOR

Regimens：Placebo and AG regimens.

Drug: Paclitaxel(Albumin Bound) and Gemcitabine; Drug: Placebo

Interventions

Camrelizumab DRUG

PD-1 antibody（Camrelizumab）, 200mg, D1; every 21 days as a cycle.

Treatment arm

Paclitaxel(Albumin Bound) and Gemcitabine DRUG

Paclitaxel(Albumin Bound), 125 mg/m2D18; Gemcitabine, 1000mg/m2D1, 8;every 21 days as a cycle.

Control arm; Treatment arm

Placebo DRUG

Placebo, 200mg, D1; every 21 days as a cycle.

Control arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.)

You may not qualify if:

• \. Patients with central nervous system metastasis. 2. Patients only have local advanced diseases. 3. Patients have uncontrolled pleural, pericardial or abdominal effusion requiring drainage.
• \. Patients with history of allergy to monoclonal antibodies, any component of SHR-1210, paclitaxel(Albumin Bound) and Gemcitabine.
• \. 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.
• \. 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.
• \. 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.
• \. Patients who have received major surgery within 4 weeks before the first dose of administration.
• \. 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.
• \. 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.
• \. Patients with active hepatitis B or hepatitis C. 19. Patients with any other malignant tumors diagnosed within 5 years before the first administration.
• \. Pregnant or lactating women. 21. According to the researchers, participants have other factors that may force them to end up the study.

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (6)

Ruijin hospital

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Shanghai General Hospital

Shanghai, Shanghai Municipality, 200080, China

RECRUITING

Renji hospital

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

camrelizumab; Taxes; Gemcitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Economics; Health Care Economics and Organizations; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Central Study Contacts

Liwei Wang, Doctor

CONTACT

+86 16621086648; lwwang@163.com

Tiebo Mao, Doctor

CONTACT

+86 16621086648; maotb4@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All participant and investigators are masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of department of oncology

Model Details: Patients are assigned into 2 arms randomly of 1：1.

Study Record Dates

• First Submitted: December 15, 2020
• First Posted: December 19, 2020
• Study Start: March 4, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: April 2, 2024

Record last verified: 2024-03

Locations

CN (6)