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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
401
PD-1 antibody(Camrelizumab), 200mg, D1; every 21 days as a cycle.
Paclitaxel(Albumin Bound), 125 mg/m2D18; Gemcitabine, 1000mg/m2D1, 8;every 21 days as a cycle.
Placebo, 200mg, D1; every 21 days as a cycle.
Ruijin hospital
Shanghai, Shanghai Municipality, China
RECRUITINGShanghai Cancer Center
Shanghai, Shanghai Municipality, China
RECRUITINGZhongshan Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGShanghai General Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGRenji hospital
Shanghai, Shanghai Municipality, China
RECRUITINGChanghai Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGProgress free survival
Time until progress free since randomized.
Time frame: 3 years
Objective Response Rate
Rate of participants with complete response and partial response.
Time frame: 3 years
Disease Control Rate
Rate of participants with complete response and partial response and stable disease.
Time frame: 3 years
Duration of Response
Time until progress(PD) since first evaluation as CR or PR.
Time frame: 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.