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Trial Title:
Camrelizumab Combined With Irinotecan or Albumin Paclitaxel for Second-line Treatment of Advanced Gastric Cancer
NCT ID:
NCT05669807
Condition:
Second Line Treatment of Gastric Cancer
Conditions: Official terms:
Stomach Neoplasms
Paclitaxel
Irinotecan
Albumin-Bound Paclitaxel
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Camrelizumab
Description:
200mg d1, the first day, every 14 days as a cycle
Arm group label:
A: Camrelizumab+Albumin-bound paclitaxel
Arm group label:
B: Camrelizumab+Irinotecan
Other name:
Camrel
Intervention type:
Drug
Intervention name:
Albumin-Bound Paclitaxel
Description:
100 mg/m2, the 1st, 8th and 15th days, every 28 days as a cycle
Arm group label:
A: Camrelizumab+Albumin-bound paclitaxel
Other name:
ABP
Intervention type:
Drug
Intervention name:
Irinotecan
Description:
180 mg/m2, the first day, every 14 days as a cycle
Arm group label:
B: Camrelizumab+Irinotecan
Other name:
Iri
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
15 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
December 2022
Completion date:
November 2025
Lead sponsor:
Agency:
Zhejiang Cancer Hospital
Agency class:
Other
Source:
Zhejiang Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05669807
