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

Advanced Colorectal Cancer Clinical Trial

Official title:

A Single Arm, Open-label, Single Center Phase II Study of Surufatinib Combined With PD-1 in Patients With Advanced MSS-Type Colorectal Cancer Treated With Standard First-line Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04764006
• Other study ID #: HMPL-012-SPRING-C101
• Status: Recruiting
• Phase: Phase 2
• Start date: October 13, 2021
• Est. completion date: November 1, 2023

Study information

• Verified date: February 2021
• Source: Fujian Cancer Hospital
• Contact: Zengqing Guo
• Phone: 86-13905918836
• Email: gzq_005[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: November 1, 2023
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• Surufatinib
Surufatinib(250mg ,qd,po)+Sintilimab(200mg,q3w,iv),21 days for a cycle.The curative effect was evaluated every 8 weeks.

Locations

Country	Name	City	State
China	China, Fujian	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate (ORR)	CR + PR rate according to the RECIST version 1.1 guidelines.	up to 12 months
Secondary	Progression Free Survival (PFS)	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).	up to 12 months
Secondary	Overall survival time	Disease control rate (DCR):CR + PR + SD rate according to the RECIST version 1.1 guidelines.	up to 36 months
Secondary	Assess the anti-tumor activity:DCR	Disease control rate (DCR):CR + PR + SD rate according to the RECIST version 1.1 guidelines.	up to 12 months