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

Launched by SUN YAT-SEN UNIVERSITY · Jul 22, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a combination of three medications—Surufatinib, Sintilimab, and Capecitabine—to see if they can help patients with metastatic adenocarcinoma of the small intestine or appendix. This is specifically for patients who have already received treatment for their cancer but didn't respond well. The goal is to find out how safe this combination is and determine the best dosage for future studies. The trial is currently looking for participants aged between 18 and 75 who have been diagnosed with these specific types of cancer and have already undergone at least one prior treatment.

Participants in this study can expect to receive the combination treatment while being closely monitored for any side effects and how well the treatment works. To join the trial, candidates must meet certain health criteria, such as having measurable cancer and being in good overall health, while also not having received certain other cancer treatments before. It's important to talk to a healthcare provider to see if this trial might be a suitable option.

Gender

ALL

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setting should have progressed during or within 6 months of completion of adjuvant therapy. 4.2 Subjects who have withdrawn from standard treatment due to unacceptable toxicity warranting discontinuation of treatment and precluding retreatment with the same agent prior to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.