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

NCT04764006 | Unknown Phase 2

• 1 other identifier: HMPL-012-SPRING-C101
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  CR + PR rate according to the RECIST version 1.1 guidelines.

  up to 12 months

Secondary Outcomes (3)

• Progression Free Survival (PFS)

  up to 12 months

• Overall survival time

  up to 36 months

• Assess the anti-tumor activity:DCR

  up to 12 months

Study Arms (1)

Surufatinib plus Sintilimab

EXPERIMENTAL

Drug: Surufatinib plus Sintilimab Surufatinib will be given orally. Sintilimab will be given intravenously

Drug: Surufatinib

Interventions

Surufatinib DRUG

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

Also known as: HMPL-012

Surufatinib plus Sintilimab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, age18-75 years.
• Pathologically confirmed unresectable locally advanced or advanced MSS-Type metastatic colorectal adenocarcinoma .
• 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.
• Eastern Cooperative Oncology Group (ECOG) performance status: 0 or 1.
• Life expectancy \> 12 weeks.
• Have measurable disease based on RECIST 1.1.

You may not qualify if:

• 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.
• Prior receipt of Surufatinib.
• 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).
• 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.
• Any life-threatening bleeding event or grade 3 or 4 bleeding requiring blood transfusion, endoscopy, or surgery with 3 months prior to dosing.

Sponsors & Collaborators

• Fujian Cancer Hospital: lead

Study Sites (1)

China, Fujian

Fuzhou, Fujian, 350014, China

RECRUITING

MeSH Terms

Interventions

surufatinib

Central Study Contacts

Zengqing Guo

CONTACT

86-13905918836; gzq_005@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2021
• First Posted: February 21, 2021
• Study Start: October 13, 2021
• Primary Completion: October 1, 2022
• Study Completion: November 1, 2023
• Last Updated: November 4, 2021

Record last verified: 2021-02

Locations

CN (1)