Trials / Unknown
UnknownNCT04152889
A Study to Evaluate Camrelizumab in Combination With Docetaxel +S-1 as Adjuvant Treatment Therapy in Stage III Gastric Cancer
A Study to Evaluate Camrelizumab in Combination With Docetaxel +S-1 Sequenced by Camrelizumab+S-1 as Adjuvant Treatment Therapy in Stage III Gastric Cancer (PD-L1 + / MSI-H / EBV +/dMMR)
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- Sponsor
- RenJi Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate the efficacy and safety of Camrelizumab in Combination With Docetaxel +S-1 Sequenced by Camrelizumab+S-1 as Adjuvant Treatment Therapy in Stage III Gastric Cancer (PD-L1 + / MSI-H / EBV +/dMMR) . Secondary study objective: To observe and evaluate the overall survival and adverse events of Camrelizumab in Combination With Docetaxel +S-1 Sequenced by Camrelizumab+S-1 as Adjuvant Treatment Therapy in Stage III Gastric Cancer (PD-L1 + / MSI-H / EBV +/dMMR). To evaluate the safety ofCamrelizumab in Combination With Docetaxel +S-1 Sequenced by Camrelizumab+S-1 as Adjuvant Treatment Therapy in Stage III Gastric Cancer (PD-L1 + / MSI-H / EBV +/dMMR). Objective: To explore the incidence of PD-L1 + / MSI-H / EBV + /dMMR in stage III gastric cancer. To explore the correlation of PD-L1 + / MSI-H / EBV + /dMMR in stage III gastric cancer.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Camrelizumab | Camrelizumab, 200 mg solution intravenously for 30 min in first day every 3 weeks. Repeated every 21 days. 21 days for a cycle. |
| DRUG | S-1 | Tegafur-gimeracil-oteracil potassium: 80 - 120 mg bid orally in 14 days, followed by 7 days off. Rrepeated every 21 days. 21 days for a cycle. |
| DRUG | Docetaxel | Docetaxel: 40 mg/m\^2 solution intravenously for 1 hour in first day every 3 weeks. Repeated every 21 days, 21 days for a cycle, from second cycle to seventh cycle. |
Timeline
- Start date
- 2020-04-14
- Primary completion
- 2022-04-01
- Completion
- 2022-12-01
- First posted
- 2019-11-05
- Last updated
- 2020-04-20
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04152889. Inclusion in this directory is not an endorsement.