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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат Surufatinib
  Surufatinib will be given 200/250 mg po. qd.
• Препарат Sintilimab
  Sintilimab administered IV at a dose of 200mg every 3 weeks.
• Препарат Capecitabine
  Capecitabine will be given 2 weeks on/1 week off (1000 mg/m2 BID po.)

Первичные конечные точки

• Progression-free survival (PFS) [Срок оценки: 2 year]

Вторичные конечные точки (4)

• Objective response rate (ORR) [Срок оценки: 2 year]
• Overall Survival (OS) [Срок оценки: 2 year]
• Disease Control Rate (DCR) [Срок оценки: 2 year]
• Safety variables (Incidence of Adverse Events [Safety and Tolerability]) [Срок оценки: 2 year]

Критерии участия

Критерии включения

• Histological or cytological documentation of adenocarcinoma of Small Intestine or Appendix Carcinoma. All other histological types are excluded.
• Subjects with metastatic adenocarcinoma of Small Intestine or Appendix Carcinoma.
• 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 . 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setting should have progressed during or within 6 months of completion of adjuvant therapy. 4.2 Subjects who have withdrawn from standard treatment due to unacceptable toxicity warranting discontinuation of treatment and precluding retreatment with the same agent prior to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)
• Subjects 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.

Критерии исключения

• 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 that acts on T cell costimulation or checkpoint pathways.
• 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 \[Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor invades lamina propria)\].
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The Sixth Affiliated Hospital of Sun Yat-sen University — Гуанчжоу

Идентификаторы

NCT: NCT05472948 · GIHSYSU-23

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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