RecruitingPhase 2NCT05472948

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


Sponsor

Sun Yat-sen University

Enrollment

36 participants

Start Date

Feb 1, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Capecitabine, a drug called Sintilimab, and others for people with adenocarcinoma of small intestine, appendix carcinoma, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 70 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSurufatinib

Surufatinib will be given 200/250 mg po. qd.

DRUGSintilimab

Sintilimab administered IV at a dose of 200mg every 3 weeks.

DRUGCapecitabine

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


Locations(1)

The Sixth Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

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NCT05472948


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