Surufatinib Combined With Sintilimab for Advanced MSS-Type Colorectal Cancer : a Phase II Study

Phase 2

• Conditions: Advanced Colorectal Cancer
• Interventions: Drug: Surufatinib

• Registration Number: NCT04764006
• Lead Sponsor: Fujian Cancer Hospital

Brief Summary

A phase II study to assess the efficacy and safety of Surufatinib combined with Sintilimab as a second-line treatment in patients with advanced MSS-Type CRC.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-02
• Study First Submitted: 2021-02-18
• Study First Submitted QC: 2021-02-18
• Study First Posted: 2021-02-21
• Study Start: 2021-10-13
• Last Update Submitted: 2021-10-27
• Last Update Posted: 2021-11-04
• Primary Completion: 2022-10-01
• Study Completion: 2023-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1. For inclusion in study, patient must provide a written informed consent.
2. Male or female, age18-75 years.
3. Pathologically confirmed unresectable locally advanced or advanced MSS-Type metastatic colorectal adenocarcinoma .
4. The patient had previously failed standard first-line systemic chemotherapy,Prior adjuvant and neo-adjuvant therapy is permitted (chemotherapy, radiotherapy, investigational agents) if 6 months or more have passed since completion of therapy.
5. Eastern Cooperative Oncology Group (ECOG) performance status: 0 or 1.
6. Life expectancy > 12 weeks.
7. Have measurable disease based on RECIST 1.1.

Exclusion Criteria

1. Any therapy with anti-PD-1, or anti-PD-L1/l2 antibodies or anti-cytotoxic T lymphocyte associated antigen-4 (CTLA-4) antibody (or any other antibody acting on T cell costimulatory or checkpoint pathway) or fruquintinib treatment in previous.
2. Prior receipt of Surufatinib.
3. History of any active autoimmune disease or autoimmune disease, including but not limited to interstitial pneumonia, uveitis, inflammatory bowel disease, hepatitis, pituitary inflammation, vasculitis, systemic lupus erythematosus, etc. (except patients with hypothyroidism that can be controlled only by hormone replacement therapy and patients with type I diabetes who only need insulin replacement therapy).
4. History of gastrointestinal perforation and/or fistula, ileus, inflammatory bowel disease, or extensive enterotomy (partial colectomy or extensive enterotomy with chronic diarrhea), Crohn's disease, ulcerative colitis, or chronic diarrhea within 6 months prior to first dosing.
5. Any life-threatening bleeding event or grade 3 or 4 bleeding requiring blood transfusion, endoscopy, or surgery with 3 months prior to dosing.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Surufatinib plus Sintilimab	Surufatinib	Drug: Surufatinib plus Sintilimab Surufatinib will be given orally. Sintilimab will be given intravenously

Primary Outcome Measures

Name	Time	Method
Objective response rate (ORR)	up to 12 months	CR + PR rate according to the RECIST version 1.1 guidelines.

Secondary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS)	up to 12 months	To assess the efficacy of Surufatinib Combined With Chemotherapy as second-line therapy to Advanced CRC, patients by assessment of progression free survival (PFS) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
Assess the anti-tumor activity:DCR	up to 12 months	Disease control rate (DCR):CR + PR + SD rate according to the RECIST version 1.1 guidelines.
Overall survival time	up to 36 months	Disease control rate (DCR):CR + PR + SD rate according to the RECIST version 1.1 guidelines.

Trial Locations

Locations (1)

China, Fujian; 🇨🇳 Fuzhou, Fujian, China