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

  • STATUS
    Recruiting
  • days left to enroll
    34
  • participants needed
    10
  • sponsor
    Fujian Cancer Hospital
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Updated on 15 November 2021
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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.

Details
Condition Advanced Colorectal Cancer
Treatment Surufatinib
Clinical Study IdentifierNCT04764006
SponsorFujian Cancer Hospital
Last Modified on15 November 2021

Eligibility

 Yes No Not Sure

Inclusion Criteria

For inclusion in study, patient must provide a written informed consent
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

Exclusion Criteria

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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