Surufatinib and Sintilimab in Combination With Capecitabine for Metastatic Adenocarcinoma of Small Intestine or Appendix Carcinoma
NCT05472948 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36
Last updated 2025-12-17
Summary
To explore the safety and efficacy of Surufatinib and Sintilimab in Combination With Capecitabine in Patients With Previously Treated Metastatic Adenocarcinoma of Small Intestine or Appendix Carcinoma : a Single-arm, a Single-center , Phase 2 Trial. Meanwhile, Exploring the maximum tolerant dose or recommended II research dose of Surufatinib combined with a fixed dose of Sintilimab and Capecitabine using 3 + 3 dose climbing experiment.
Conditions
- Adenocarcinoma of Small Intestine
- Appendix Carcinoma
- Metastatic
Interventions
- DRUG
-
Surufatinib
Surufatinib will be given 200/250 mg po. qd.
- DRUG
-
Sintilimab
Sintilimab administered IV at a dose of 200mg every 3 weeks.
- DRUG
-
Capecitabine will be given 2 weeks on/1 week off (1000 mg/m2 BID po.)
Sponsors & Collaborators
-
Sun Yat-sen University
lead OTHER
Principal Investigators
-
Yanhong Deng, Ph.D · Sixth Affiliated Hospital, Sun Yat-sen University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-02-01
- Primary Completion
- 2027-12-30
- Completion
- 2027-12-30
Countries
- China
Study Locations
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