Actively Recruiting
Surufatinib and Sintilimab in Combination With Capecitabine for Metastatic Adenocarcinoma of Small Intestine or Appendix Carcinoma
Led by Sun Yat-sen University · Updated on 2025-12-17
36
Participants Needed
1
Research Sites
256 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Surufatinib and Sintilimab in Combination With Capecitabine for Metastatic Adenocarcinoma of Small Intestine or Appendix Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histological or cytological confirmation of adenocarcinoma of the small intestine or appendix carcinoma; all other histological types excluded
- Diagnosis of metastatic adenocarcinoma of the small intestine or appendix carcinoma
- Previous failure of at least one line of treatment
- Disease progression during or within 3 months after last approved standard therapy, or within 6 months after adjuvant therapy completion
- Patients who stopped standard treatment due to unacceptable toxicity that prevents retreatment before disease progression are eligible
- Prior treatment with Avastin (bevacizumab) allowed
- Measurable or non-measurable disease per RECIST version 1.1
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 1
- Life expectancy of at least 3 months
- Adequate bone marrow, liver, and kidney function based on protocol-required lab tests
You will not qualify if you...
- Prior treatment with Surufatinib
- Previous use of anti-PD-1, anti-PD-L1, anti-CTLA-4 antibodies, or other drugs targeting T cell costimulation or checkpoint pathways
- Other cancers distinct from colorectal cancer within 5 years, except curatively treated cervical cancer in situ, non-melanoma skin cancer, and superficial bladder tumors
- Cardiological diseases including congestive heart failure, unstable angina, myocardial infarction, or cardiac arrhythmias requiring treatment
- Uncontrolled hypertension despite optimal medical management (systolic ≥150 mmHg or diastolic ≥90 mmHg)
- Pleural effusion or ascites causing breathing problems; arterial or venous thrombotic or embolic events
- History or presence of brain metastases
- Interstitial lung disease with current symptoms
- Systemic anticancer therapy within 4 weeks prior to trial or during the trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510655
Actively Recruiting
Research Team
Y
Yanhong Deng, Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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