Trials / Unknown
UnknownNCT04267549
Conversion Therapy of Sintilimab in Combination With Apatinib and Chemotherapy in Stage IV Gastric Cancer
Efficacy and Safety of Conversion Therapy With Sintilimab in Combination With Chemotherapy and Apatinib in Patients With Stage IV Gastric Cancer
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 47 (actual)
- Sponsor
- Tianjin Medical University Cancer Institute and Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This is a single-arm, phase II study aiming to evaluate the feasibility and efficacy of sintilimab (PD-1 inhibitor) in combination of apatinib and two-drug chemotherapy (S-1 plus nab-paclitaxel) as conversion therapy in patients with stage IV gastric cancer in China.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | sintilimab | a checkpoint inhibitor via blocking PD-1 (programmed cell death-1) site of signaling. |
| DRUG | apatinib | a multi-target anti-angiogenic tyrosine kinase inhibitor (TKI) |
| DRUG | S1 | S-1 is an oral fluoropyrimidine consisting of tegafur (a prodrug that is converted to fluorouracil, mainly in liver microsomes but also in tumour tissue), gimeracil (an inhibitor of dihydropyrimidine dehydrogenase, which degrades 5-FU), and oteracil (which inhibits the phosphorylation of 5-FU in the gastrointestinal tract, thereby reducing the toxic effects of 5-FU in the intestinum). |
| DRUG | Nab paclitaxel | Nab paclitaxel is a albumin-bound well tolerated paclitaxel than traditional paclitaxel |
Timeline
- Start date
- 2019-05-01
- Primary completion
- 2022-12-01
- Completion
- 2023-08-30
- First posted
- 2020-02-13
- Last updated
- 2023-07-06
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04267549. Inclusion in this directory is not an endorsement.