Surufatinib and Sintilimab in Combination With Capecitabine for Metastatic Adenocarcinoma of Small Intestine or Appendix Carcinoma
NCT ID: NCT05472948
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
36 participants
INTERVENTIONAL
2023-02-01
2027-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Surufatinib and Sintilimab in Combination With Capecitabine
Patients were given solventinib (a "3+3" design was adopted in the dose exploration phase, with two dose levels of 200mg and 250mg for dose exploration; after the recommended dose was determined in the dose exploration phase, the dose amplification phase was entered), once a day (QD) for continuous administration
* sindilizumab, 200mg, iv every 3 weeks (Q3W)
* Capecitabine, 1000mg/m2, twice a day (BID, once in the morning and once in the evening), orally after meals, stopped for 1 week after 2 weeks of treatment;
The three-drug combination therapy was continued every 3 weeks in a cycle until patients developed disease progression or met other criteria for termination of study treatment specified in the protocol.
Surufatinib
Surufatinib will be given 200/250 mg po. qd.
Sintilimab
Sintilimab administered IV at a dose of 200mg every 3 weeks.
Capecitabine
Capecitabine will be given 2 weeks on/1 week off (1000 mg/m2 BID po.)
Interventions
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Surufatinib
Surufatinib will be given 200/250 mg po. qd.
Sintilimab
Sintilimab administered IV at a dose of 200mg every 3 weeks.
Capecitabine
Capecitabine will be given 2 weeks on/1 week off (1000 mg/m2 BID po.)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
70 Years
ALL
No
Sponsors
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Sun Yat-sen University
OTHER
Responsible Party
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Yanhong Deng
Director of Medical Oncology, Clinical Professor
Principal Investigators
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Yanhong Deng, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Sixth Affiliated Hospital, Sun Yat-sen University
Locations
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The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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GIHSYSU-23
Identifier Type: -
Identifier Source: org_study_id