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This is a Phase I/II , Open-label , Investigator-initiated Trail of Camrelizumab (an Anti-PD-1 Inhibitor), Apatinib (VEGFR2 Inhibitor) and Nab-paclitaxel as Second-line Treatment in Advanced Gastric Cancer The study was designed in two stages, the first stage was the tolerance observation stage, and the second stage was the curative effect expansion stage.
The first part of the study is the Dose-finding Phase designed to establish the safety of Camrelizumab, Apatinib and Nab-paclitaxel at different dose Levels(125 mg/m2, iv. q2w, 150 mg/m2, iv. q2w, 175 mg/m2, iv. q2w or 200 mg/m2, iv. q2w). The second part of the study is the Expansion Phase designed to generate additional clinical data at specified doses .
This study aims to evaluate the safety and efficacy of Camrelizumab, Apatinib and Nab-paclitaxel in the Second-line treatment of advanced Gastric Cancer.
This trial investigated the safety and efficacy of Camrelizumab, Apatinib and Nab-paclitaxel as Second-line Treatment in Advanced Gastric Cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Camrelizumab, Apatinib and Nab-paclitaxel | Experimental | Camrelizumab was administered 200mg iv every 2 weeks, Apatinib 250 mg p.o. qd Nab-paclitaxel 125 mg/m2, 150 mg/m2, 175 mg/m2 or 200 mg/m2, iv. q2w |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Camrelizumab, Apatinib and Nab-paclitaxel | Drug | Camrelizumab was administered 200mg iv every 2 weeks, Apatinib was administered 250 mg p.o. qd Nab-paclitaxel was administered 125 mg/m2, 150 mg/m2, 175 mg/m2 or 200 mg/m2, iv. q2w |
| Measure | Description | Time Frame |
|---|---|---|
| MTD /DLT (phase I) | Maximum Tolerated Dose/Dose Limiting Toxicity | Within four weeks after administration |
| ORR(phase II) | Overall Response Rate | from the first drug administration up to two years |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events (phase I/II) | adverse events/serious adverse events | from the first drug administration to within 90 days for the last drug dose |
| PFS(phase I/II) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guanghai Dai, PhD | Contact | 13801232381 | daigh301@vip.sina.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese PLA General Hospital | Recruiting | Beijing | 100853 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38347177 | Derived | Gou M, Zhang Y, Wang Z, Qian N, Dai G. PD-1 inhibitor combined with albumin paclitaxel and apatinib as second-line treatment for patients with metastatic gastric cancer: a single-center, single-arm, phase II study. Invest New Drugs. 2024 Apr;42(2):171-178. doi: 10.1007/s10637-024-01425-3. Epub 2024 Feb 12. |
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| ID | Term |
|---|---|
| C000631724 | camrelizumab |
| C553458 | apatinib |
| C520255 | 130-nm albumin-bound paclitaxel |
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Progression-Free-Survival
| from the first drug administration up to two years |