Surgical Conversion of Candonilimab (AK104) Plus Paclitaxel, S-1 and Apatinib for Unresectable Advanced G/GEJ Cancer
Gastric Cancer
About this trial
This is an interventional treatment trial for Gastric Cancer
Eligibility Criteria
Inclusion Criteria: Males or females aged ≥ 18 to ≤ 75 years at the time of signing informed consent. Clinically diagnosed unresectable stage IV gastric (G) or gastroesophageal junction (GEJ) adenocarcinoma by CT/MRI/Positron Emission Tomography (PET) -CT. Not received prior systemic therapy for stage IV G/GEJ adenocarcinoma At least one measurable tumor lesion per RECIST v1.1; Major organ functions are adequate; Expected survival is ≥ 3 months; Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1; Exclusion Criteria: Human Epidermal GrowthFactor Receptor 2 (HER2)-positive G/GEJ adenocarcinoma; Previously received immune checkpoint inhibitors, including but not limited to programmed death 1 (PD-1) inhibitors and cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) inhibitors; Central nervous system, lung, or bone metastases; Known history of active or autoimmune disease; Known history of other malignancies; Known history of severe cardiovascular and cerebrovascular diseases; Known history of gastrointestinal bleeding within the past 3 months or significant tendency to gastrointestinal bleeding; Active infection or fever of unknown origin; Known history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, and severe impairment of lung function; Known history of immunodeficiency, positive HIV antibody (HIVAb) test, or other acquired or congenital immunodeficiency disorder, or active hepatitis; Known history of mental disorder or psychoactive substance abuse; Hypersensitivity to the drugs of this regimen;
Sites / Locations
- Tianjin Medical University Cancer Institute and HospitalRecruiting
Arms of the Study
Arm 1
Experimental
AK104 plus apatinib, paclitaxel and S-1
AK104 (10mg/kg, iv, Q3W) is combined with apatinib (250mg, po, qd), paclitaxel (non-peritoneal metastasis: 130mg/m2, iv, D1; peritoneal metastasis: 90mg/m2, iv, 40mg/m2, ip, D1) and S-1(60mg, po, bid, D1-D14) for up to 6 cycle for up to 6 cycles.