Combination treatment for metastatic adenocarcinoma of the small intestine or appendix

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

This study is testing a new combination of three medications to see if they can help people with advanced cancer of the small intestine or appendix who haven't responded to other treatments.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Sun Yat-sen University (Academic / other)
• Drugs / interventions: bevacizumab, Surufatinib, immunotherapy, Sintilimab
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT05472948 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and efficacy of a combination of Surufatinib, Sintilimab, and Capecitabine in patients with previously treated metastatic adenocarcinoma of the small intestine or appendix. It is a single-arm, single-center Phase 2 trial that aims to determine the maximum tolerated dose of Surufatinib alongside fixed doses of Sintilimab and Capecitabine using a dose escalation method. The trial focuses on patients who have experienced disease progression after standard therapies.

Who should consider this trial

Good fit: Ideal candidates are patients with histologically confirmed metastatic adenocarcinoma of the small intestine or appendix who have failed at least one prior treatment.

Not a fit: Patients with other histological types of cancer or those who have not received prior treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with metastatic adenocarcinoma of the small intestine or appendix who have limited treatment options.

How similar studies have performed: While this approach is being explored in this specific context, similar combinations have shown promise in other cancer types, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

1. Histological or cytological documentation of adenocarcinoma of Small Intestine or Appendix Carcinoma. All other histological types are excluded.
2. Subjects with metastatic adenocarcinoma of Small Intestine or Appendix Carcinoma.
3. Subjects must have failed at least one line of prior treatment.
4. Progression during or within 3 months following the last administration of approved standard therapies . 4.1 Subjects an adjuvant setting should have progressed during or within 6 months of completion of adjuvant therapy. 4.2 Subjects who have withdrawn from standard treatment due to unacceptable toxicity warranting discontinuation of treatment and precluding retreatment with the same agent prior to progression of disease will also be allowed into the study. 4.3 Subjects may have received prior treatment with Avastin (bevacizumab)
5. Subjects must have measurable or non measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria, version 1.1.
6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 1.
7. Life expectancy of at least 3 months.
8. Adequate bone marrow, liver and renal function as assessed by the laboratory required by protocol.

Exclusion Criteria:

1. Prior treatment with Surufatinib
2. Previously received anti-programmed death-1 (PD-1) or its ligand (PD-L1) antibody, anti-cytotoxic T lymphocyte-associated antigen 4 (cytotoxic T- lymphocyte-associated Protein 4, CTLA-4) antibody or other drug/antibody that acts on T cell costimulation or checkpoint pathways.
3. Previous or concurrent cancer that is distinct in primary site or histology from colorectal cancer within 5 years prior to randomization EXCEPT for curatively treated cervical cancer in situ, non-melanoma skin cancer and superficial bladder tumors \[Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor invades lamina propria)\].
4. Cardiological disease including Congestive heart failure, Unstable angina, Myocardial infarction, Cardiac arrhythmias requiring anti-arrhythmic therapy.
5. Uncontrolled hypertension. (Systolic blood pressure 150 mmHg or diastolic pressure 90 mmHg despite optimal medical management).
6. Pleural effusion or ascites that causes respiratory compromise. Arterial or venous thrombotic or embolic events.
7. Any history of or currently known brain metastases.
8. Interstitial lung disease with ongoing signs and symptoms at the time of informed consent.
9. Systemic anticancer therapy including cytotoxic therapy, signal transduction inhibitors, immunotherapy, and hormonal therapy during this trial or within 4 week.

Where this trial is running

Guangzhou, Guangdong

• The Sixth Affiliated Hospital of Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Principal investigator: Yanhong Deng, Ph.D — Sixth Affiliated Hospital, Sun Yat-sen University
• Study coordinator: Yanhong Deng, Ph.D

Conditions Adenocarcinoma of Small Intestine; Appendix Carcinoma; Metastatic