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Status unknownNCT04674956Updated Apr 2, 2024

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

A Phase 3 interventional study of Camrelizumab and Paclitaxel(Albumin Bound) and Gemcitabine in Pancreatic Cancer Stage IV and Pancreatic Cancer Metastatic, sponsored by RenJi Hospital. Status unknown at 6 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-02.

Sponsored by RenJi Hospital · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2024), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
401
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

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.
Read the 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.

02

Conditions studied

  • Pancreatic Cancer Stage IV
  • Pancreatic Cancer Metastatic
03

In context

Pancreatic Neoplasms

3,310 studies on the registry are indexed under Pancreatic Neoplasms; 910 are open to participants now.

This study's planned enrollment of 401 is above the median of 46 across 2,480 interventional studies indexed under Pancreatic Neoplasms.

Browse Pancreatic Neoplasms studies →

Lead sponsor

RenJi Hospital is the lead sponsor of 550 studies on the registry; 248 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
401 participants (estimated)

Study arms

  • Experimental
    Treatment arm

    Regimens:anti-PD1 antibody and AG regimens.

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

  • Placebo comparator
    Control arm

    Regimens:Placebo and AG regimens.

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

Interventions

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

  • DrugPaclitaxel(Albumin Bound) and Gemcitabine

    Drug pages: Paclitaxel · Gemcitabine

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

  • DrugPlacebo

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

06

What researchers measure

Primary outcomes

  1. Progress free survival

    Time until progress free since randomized.

    Time frame: 3 years

Secondary outcomes

  1. Objective Response Rate

    Rate of participants with complete response and partial response.

    Time frame: 3 years

  2. Disease Control Rate

    Rate of participants with complete response and partial response and stable disease.

    Time frame: 3 years

  3. Duration of Response

    Time until progress(PD) since first evaluation as CR or PR.

    Time frame: 2 years

Other outcomes

  1. CA19-9 in serum

    CA19-9 in serum

    Time frame: 3 years

07

Study locations

6 of 6 sites recruiting
  • 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
08

References and documents

Individual participant data

Plan to share: Undecided — Share within six months after the trial complete. IPD: Study protocol,statistical analysis plan,informed consent form and clinical study report.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 2, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04674956
Lead sponsor
RenJi Hospital
Responsible party
liwei wang (Director of department of oncology, RenJi Hospital) — Principal investigator
First posted
Dec 19, 2020
Start date
Mar 4, 2021
Primary completion
Dec 31, 2024 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Apr 2, 2024

Study contacts

Liwei Wang, Doctor
Contact
lwwang@163.com
+86 16621086648
Tiebo Mao, Doctor
Contact
maotb4@163.com
+86 16621086648

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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