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New treatment option for Adenocarcinoma of Small Intestine
Official title Surufatinib and Sintilimab in Combination With Capecitabine for Metastatic Adenocarcinoma of Small Intestine or Appendix Carcinoma
ClinicalTrials.gov ID: NCT05472948
What this study is testing
What is Surufatinib?
Surufatinib is an investigational medicine, being studied as a potential treatment for adenocarcinoma of small intestine.
Also referred to as SULANDA.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Histological or cytological documentation of adenocarcinoma of Small Intestine or Appendix Carcinoma. All other histological types are excluded.
- people with metastatic adenocarcinoma of Small Intestine or Appendix Carcinoma.
- people must have failed at least one line of prior treatment.
- Progression during or within 3 months following the last administration of approved standard therapies . 4.1 people an adjuvant setting should have...
- people must have measurable or non measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria, version 1.1.
You likely can't join if
- Prior treatment with Surufatinib
- Previously received anti-programmed death-1 (PD-1) or its ligand (PD-L1) antibody, anti-cytotoxic T lymphocyte-associated antigen 4 (cytotoxic T-...
- Previous or concurrent cancer that is distinct in primary site or histology from colorectal cancer within 5 years prior to randomization EXCEPT for...
- Cardiological disease including Congestive heart failure, Unstable angina, Myocardial infarction, Cardiac arrhythmias requiring anti-arrhythmic...
- Uncontrolled hypertension. (Systolic blood pressure 150 mmHg or diastolic pressure 90 mmHg despite optimal medical management).
- Pleural effusion or ascites that causes respiratory compromise. Arterial or venous thrombotic or embolic events.
See the full eligibility criteria
- Histological or cytological documentation of adenocarcinoma of Small Intestine or Appendix Carcinoma. All other histological types are excluded.
- people with metastatic adenocarcinoma of Small Intestine or Appendix Carcinoma.
- people must have failed at least one line of prior treatment.
- Progression during or within 3 months following the last administration of approved standard therapies . 4.1 people an adjuvant setting should have progressed during or within 6 months of completion of adjuvant therapy...
- people must have measurable or non measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria, version 1.1.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 1.
- Life expectancy of at least 3 months.
- Adequate bone marrow, liver and renal function as assessed by the laboratory required by protocol.
- Prior treatment with Surufatinib
- 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...
- 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...
- Cardiological disease including Congestive heart failure, Unstable angina, Myocardial infarction, Cardiac arrhythmias requiring anti-arrhythmic therapy.
- Uncontrolled hypertension. (Systolic blood pressure 150 mmHg or diastolic pressure 90 mmHg despite optimal medical management).
- Pleural effusion or ascites that causes respiratory compromise. Arterial or venous thrombotic or embolic events.
- Any history of or currently known brain metastases.
- Interstitial lung disease with ongoing signs and symptoms at the time of informed consent.
- Systemic anticancer therapy including cytotoxic therapy, signal transduction inhibitors, immunotherapy, and hormonal therapy during this trial or within 4 week.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.