Second Line Treatment of Gastric Cancer
Conditions
Brief summary
This study is a multicenter, open, and randomized clinical phase II exploratory study. The pick the winner study design is used to determine and select which chemotherapy drug (irinotecan vs. albumin plus paclitaxel) is more effective in the second-line treatment of advanced gastric cancer, and it is more hopeful to carry out the follow-up phase III study in the second-line treatment of advanced gastric cancer (karelizumab+chemotherapy vs. chemotherapy). The study plans to include 184 patients with advanced gastric cancer who have received first-line platinum+fluorouracil progression, randomly use albumin paclitaxel+carrelizumab or irinotecan+carrelizumab second-line therapy, and observe the objective effective rate (ORR), total survival time (OS), progression free survival time (PFS), treatment related adverse reactions, quality of life and other clinical indicators after receiving the above treatment, Then determine the second line scheme which is more advantageous.
Interventions
DRUGCamrelizumab
200mg d1, the first day, every 14 days as a cycle
DRUGAlbumin-Bound Paclitaxel
100 mg/m2, the 1st, 8th and 15th days, every 28 days as a cycle
DRUGIrinotecan
180 mg/m2, the first day, every 14 days as a cycle
Sponsors
Zhejiang Cancer Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age: 18-75 * ECOG score: 0 or 1 * Unresectable advanced or recurrent gastric cancer/gastroesophageal junction cancer * histologically proven adenocarcinoma * Received chemotherapy based on platinum and fluorouracil within 12 months * Patients not previously treated with paclitaxel or irinotecan * Liver function: total bilirubin, ALT and AST\<1.5 × ULN (Normal Value upper limit) * Renal function: Cr\<1.5 × ULN and creatinine clearance ≥ 40 ml/min * Echocardiography or radionuclide cardiac function test, LVEF ≥ 50% * Expected survival ≥ 3 months * Sign the informed consent form
Exclusion criteria
* Patients who have received irinotecan or paclitaxel chemotherapy in the past * ECOG PS score:\>2 * Advanced gastric cancer patients with extensive and severe peritoneal metastasis * Patients with severe liver and kidney insufficiency or cardiac insufficiency * HIV positive, active hepatitis B or C, active pulmonary tuberculosis * Patients with active autoimmune diseases, including lupus erythematosus, rheumatoid arthritis, rheumatoid arthritis, etc * Patients known to be allergic to any of the study drugs * Pregnant or lactating female patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate | up to 12 weeks | CR+PR |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | From date of randomization until the date of date of death from any cause, assessed up to 24 months | Time from random start of treatment to death from any cause |
| Progression-free Survival | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months | Time from random start of treatment to death or tumor progression due to any reason |
| Treatment related adverse reactions | 24 months | Evaluation according to CTC 4.0 |
| Quality of life assessment | 24 months | according to EORTC C30 |
Contacts
Primary ContactJi Zhu
Backup ContactJinwen Shen
Outcome results
None listed