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TerminatedNCT04427774Updated Jul 20, 2021

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

A Phase 1 interventional study of Surufatinib plus Sintilimab in Advanced or Metastatic Solid Tumors, sponsored by Innovent Biologics (Suzhou) Co. Ltd.. Terminated at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-07-20.

Sponsored by Innovent Biologics (Suzhou) Co. Ltd. · Phase 1, Interventional, and Treatment

Why this study was terminated
Policy change, not for security reasons
Phase
Phase 1
Study type
Interventional
Enrollment
8
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Advanced or Metastatic Solid Tumors

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03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 8 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.

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Lead sponsor

Innovent Biologics (Suzhou) Co. Ltd. is the lead sponsor of 192 studies on the registry; 44 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Advanced or metastatic and recurrent cancer where an appropriate treatment option is not available
  2. Have measurable disease based on RECIST 1.1
  3. Life expectancy > 12 weeks
  4. Eastern Cooperative Oncology Group (ECOG) performance status: 0 or 1

Exclusion criteria

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
8 participants (actual)

Study arms

  • Experimental
    Surufatinib plus Sintilimab

    Drug: Surufatinib plus Sintilimab

Interventions

  • DrugSurufatinib plus Sintilimab

    Surufatinib will be given orally. Sintilimab will be given intravenously

06

What researchers measure

Primary outcomes

  1. Safety and tolerability assessed by monitoring frequency, duration, and severity of adverse events (AEs)

    Time frame: Baseline through 30 days after end of treatment, up to approximately 24months

Secondary outcomes

  1. Overall response rate in subjects with measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

    Time frame: Baseline and every 6 weeks through week 48, and then every 12 weeks

07

Study locations

1 site
  • Jiangsu Province
    Nanjing, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 20, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04427774
Lead sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Responsible party
Sponsor
First posted
Jun 11, 2020
Start date
Jun 29, 2020
Primary completion
Feb 8, 2021
Completion
Apr 27, 2021
Last update
Jul 20, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.

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