Gastric Cancer
Conditions
Brief summary
This is a prospective, single-arm, open-label，single-center, phase II study, aiming to to evaluate the surgical conversion feasibility of AK104 combined with apatinib, paclitaxel and S-1 in unresectable stage IV G/GEJ cancer.
Detailed description
Eligible patients receive AK104 (10mg/kg, iv, Q3W) 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 cycles. Patients assessed by Multi-Disciplinary Treatment (MDT) to meet the criteria for surgical resection undergo gastrectomy.
Interventions
DRUGAK104
Subjects will receive AK104 until disease progression or for up to 6 cycles.
DRUGApatinib
Subjects will receive apatinib until disease progression or for up to 6 cycles.
DRUGPaclitaxel
Subjects will receive paclitaxel until disease progression or for up to 6 cycles.
DRUGS-1
Subjects will receive S-1 until disease progression or for up to 6 cycles.
Sponsors
Tianjin Medical University Cancer Institute and Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Males or females aged ≥ 18 to ≤ 75 years at the time of signing informed consent. 2. Clinically diagnosed unresectable stage IV gastric (G) or gastroesophageal junction (GEJ) adenocarcinoma by CT/MRI/Positron Emission Tomography (PET) -CT. 3. Not received prior systemic therapy for stage IV G/GEJ adenocarcinoma 4. At least one measurable tumor lesion per RECIST v1.1; 5. Major organ functions are adequate; 6. Expected survival is ≥ 3 months; 7. Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1;
Exclusion criteria
1. Human Epidermal GrowthFactor Receptor 2 (HER2)-positive G/GEJ adenocarcinoma; 2. 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; 3. Central nervous system, lung, or bone metastases; 4. Known history of active or autoimmune disease; 5. Known history of other malignancies; 6. Known history of severe cardiovascular and cerebrovascular diseases; 7. Known history of gastrointestinal bleeding within the past 3 months or significant tendency to gastrointestinal bleeding; 8. Active infection or fever of unknown origin; 9. Known history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, and severe impairment of lung function; 10. Known history of immunodeficiency, positive HIV antibody (HIVAb) test, or other acquired or congenital immunodeficiency disorder, or active hepatitis; 11. Known history of mental disorder or psychoactive substance abuse; 12. Hypersensitivity to the drugs of this regimen;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| R0 surgical conversion rate | up to 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Pathological complete response (pCR) | up to 2 years |
| Pathological major response (MPR) | up to 2 years |
| Objective response rate (ORR) | up to 2 years |
| R0 resection rate | up to 2 years |
| Progression-free survival (PFS) | up to 2 years |
| Adverse event (AE) | up to 2 years |
| Disease control rate (DCR) | up to 2 years |
Countries
China
Contacts
Primary ContactHan Liang, MD
Outcome results
None listed