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

Metastatic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05472948
• Other study ID #: GIHSYSU-23
• Status: Recruiting
• Phase: Phase 2
• Start date: February 1, 2023
• Est. completion date: November 30, 2025

Study information

• Verified date: February 2023
• Source: Sun Yat-sen University
• Contact: Yanhong Deng, Ph.D
• Phone: 86-13925106525
• Email: 13925106525[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: November 30, 2025
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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setting should have progressed during or within 6 months of completion of adjuvant therapy. 4.2 Subjects who have withdrawn from standard treatment due to unacceptable toxicity warranting discontinuation of treatment and precluding retreatment with the same agent prior to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

Related Conditions & MeSH terms

• Adenocarcinoma
• Appendiceal Neoplasms
• Appendix Carcinoma
• Carcinoma
• Metastatic

Intervention

Drug:
• 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.)

Locations

Country	Name	City	State
China	The Sixth Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival (PFS)	The PFS is defined as the time from the start of treatment to the date of first documented PD or death as a result of any cause, whichever occurred first. When a patient was alive and without progression, PFS was censored at the date of the last disease assessment.	2 year
Secondary	Objective response rate (ORR)	The percentage of subjects with total number of Complete Response (CR) + total number of Partial Response (PR).	2 year
Secondary	Overall Survival (OS)	OS is defined as the time from date of randomization to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact.	2 year
Secondary	Disease Control Rate (DCR)	DCR is defined as the percentage of subjects whose best response was not Progressive Disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) (= total number of Complete Response (CR) + total number of Partial Response (PR) + total number of Stable Disease (SD); CR, PR, or SD had to be maintained for at least 28 days from the first demonstration of that rating)	2 year
Secondary	Safety variables (Incidence of Adverse Events [Safety and Tolerability])	Safety variables will be summarized using descriptive statistics based on adverse events collection	2 year