A Study of Surufatinib Plus Sintilimab in Patients With Advanced Solid Tumor

  • STATUS
    Recruiting
  • participants needed
    95
  • sponsor
    Innovent Biologics (Suzhou) Co. Ltd.
Updated on 5 August 2020

Summary

The purpose of this study is to evaluate the safety and efficacy of Surufatinib plus Sintilimab in Patients with Advanced Solid Tumor

Details
Condition Advanced or Metastatic Solid Tumors
Age 18years - 75years
Treatment Surufatinib plus Sintilimab
Clinical Study IdentifierNCT04427774
SponsorInnovent Biologics (Suzhou) Co. Ltd.
Last Modified on5 August 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Advanced or metastatic and recurrent cancer where an appropriate treatment option is not available
Have measurable disease based on RECIST 1.1
Life expectancy > 12 weeks
Eastern Cooperative Oncology Group (ECOG) performance status: 0 or 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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