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OncoMatch/Clinical Trials/NCT05472948

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

Is NCT05472948 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Surufatinib and Sintilimab for adenocarcinoma of small intestine.

Phase 2RecruitingSun Yat-sen UniversityNCT05472948Data as of May 2026

Treatment: Surufatinib · Sintilimab · CapecitabineTo 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.

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Extracted eligibility criteria

Disease stage

Metastatic disease required

Performance status

ECOG 1–1(Restricted strenuous activity)

Prior therapy

Min 1 prior line

Must have received: approved standard therapies

Subjects must have failed at least one line of prior treatment. Progression during or within 3 months following the last administration of approved standard therapies. Subjects in adjuvant setting should have progressed during or within 6 months of completion of adjuvant therapy.

Cannot have received: Surufatinib (Surufatinib)

Prior treatment with Surufatinib

Cannot have received: anti-PD-1 therapy

Previously received anti-programmed death-1 (PD-1) or its ligand (PD-L1) antibody

Cannot have received: anti-PD-L1 therapy

Previously received anti-programmed death-1 (PD-1) or its ligand (PD-L1) antibody

Cannot have received: anti-CTLA-4 therapy

anti-cytotoxic T lymphocyte-associated antigen 4 (cytotoxic T- lymphocyte-associated Protein 4, CTLA-4) antibody

Cannot have received: other T cell costimulation or checkpoint pathway inhibitor

other drug/antibody that acts on T cell costimulation or checkpoint pathways

Lab requirements

Blood counts

adequate bone marrow function as assessed by the laboratory required by protocol

Kidney function

adequate renal function as assessed by the laboratory required by protocol

Liver function

adequate liver function as assessed by the laboratory required by protocol

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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