Trials / Unknown
UnknownNCT04089657
Apatinib Plus Sintilimab in Advanced Gastric Cancer Refractory to at Least Two Previous Chemotherapy Regimens
Apatinib Plus Sintilimab in Patients With Advanced Gastric Cancer
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- Sponsor
- Fujian Cancer Hospital · Other Government
- Sex
- All
- Age
- 20 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to assess the efficacy and safety of Apatinib combined with PD-1 antibody Sintilimab for for Chemotherapy-Refractory Advanced Metastatic Gastric Cancer
Detailed description
Patients with advanced gastric cancer (AGC) can be treated with multiple lines of chemotherapy. After second-line treatment some patients may receive third- and subsequent lines of chemotherapy if their performance status is well-preserved and they are willing to receive subsequent active treatments. Apatinib is a small-molecule VEGFR-2 tyrosine kinase inhibitor approved by the CFDA for the treatment of advanced gastric cancer. In a phase III trial, apatinib significantly improved PFS and OS compared with placebo, but the clinical benefit was modest. As a result of toxicity, 850 mg/day Apatinib may cause dose reduction and delay in some patients ,which also caused some doubts. Therefore, it is a reasonable treatment strategy by reducing the dose and combining it with another low-toxic drug to achieve similar or better effects. Some studies have shown that the combination of targeted therapy and immunotherapy may be effective in solid tumor. Sintilimab (IBI308) is a monoclonal antibody targeting programmed death-1 (PD-1). So, the investigators designed an open-label, single-arm, phase II clinical study to evaluate the efficacy and safety of apatinib combined with Sintilimab in Chemotherapy-Refractory Advanced Metastatic Gastric Cancer.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Apatinib Mesylate | Apatinib 500mg qd, oral, taken half an hour after a meal |
| DRUG | Sintilimab | Sintilimab 200mg intravenously on day 1 |
Timeline
- Start date
- 2019-12-01
- Primary completion
- 2020-12-01
- Completion
- 2021-12-01
- First posted
- 2019-09-13
- Last updated
- 2019-09-13
Source: ClinicalTrials.gov record NCT04089657. Inclusion in this directory is not an endorsement.