Trials / Unknown
UnknownNCT05030246
Trial of Surufatinib Combined With Toripalimab in the Treatment of Peritoneal Metastatic Carcinoma of Gastrointestinal or Primary Peritoneal Cancer
A Phase Ⅱ, Single-arm Study to Evaluate the Efficacy and Safety of Surufatinib Combined With Toripalimab in Peritoneal Metastatic Carcinoma of Gastrointestinal or Primary Peritoneal Cancer
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 72 (estimated)
- Sponsor
- Peking University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a phase II, single arm, open-label, single-center study to evaluate the efficacy and safety of Surufatinib combined with Toripalimab in patients with peritoneal metastatic carcinoma of gastrointestinal or primary peritoneal cancer.
Detailed description
The study population is about 72 patients with advanced peritoneal metastatic carcinoma of gastrointestinal or primary peritoneal cancer, who fails or cannot tolerate standard therapies. Surufatinib 250 mg once a day (QD) will be orally administrated and Toripalimab 240mg will be intravenously administered every 3 weeks up to documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent. For Toripalimab, the upper time limit for treatment is 2 years. The primary objective is overall survival (OS) of Surufatinib combined with Toripalimab in patients with advanced solid advanced peritoneal metastatic carcinoma of gastrointestinal or primary peritoneal cancer.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Surufatinib/Toripalimab | Surufatinib 250mg will be taken orally once daily continuously through a 21-day cycle of study treatment. Toripalimab 240mg will be intravenously administered on Day 1 of each cycle. |
Timeline
- Start date
- 2021-07-14
- Primary completion
- 2023-04-30
- Completion
- 2023-07-30
- First posted
- 2021-09-01
- Last updated
- 2021-09-01
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05030246. Inclusion in this directory is not an endorsement.