NCT05472948

Surufatinib and Sintilimab in Combination With Capecitabine for Metastatic Adenocarcinoma of Small Intestine or Appendix Carcinoma

Surufatinib and Sintilimab in Combination With Capecitabine for Previously Treated Metastatic Small Bowel Adenocarcinoma and Appendiceal Carcinoma: A Single-arm, Multi-center, Phase Ib/II Trial

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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	Capecitabine will be given 2 weeks on/1 week off (1000 mg/m2 BID po.)

Timeline

• Start date: 2023-02-01
• Primary completion: 2027-12-30
• Completion: 2027-12-30
• First posted: 2022-07-25
• Last updated: 2025-12-17

Locations

1 site across 1 country: China