Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Regorafenib Plus PD-1 Inhibitor in Patients With Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04110093
Recruitment Status : Recruiting
First Posted : October 1, 2019
Last Update Posted : October 9, 2019
Sponsor:
Information provided by (Responsible Party):
Yuan-Sheng Zang, Shanghai Changzheng Hospital

Tracking Information
First Submitted Date  ICMJE September 28, 2019
First Posted Date  ICMJE October 1, 2019
Last Update Posted Date October 9, 2019
Actual Study Start Date  ICMJE March 1, 2019
Estimated Primary Completion Date August 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 28, 2019)
  • Objective Response Rate [ Time Frame: Evaluation of tumor burden based on RECIST criteria through study completion, an average of 2 months ]
    Proportion of patients with reduction in tumor burden of a predefined amount, including complete remission and partial remission.
  • Progress Free Survival [ Time Frame: Evaluation of tumor burden based on RECIST criteria until first documented progress through study completion, an average of 2 months ]
    Time from treatment beginning until disease progression
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 28, 2019)
  • Overall Survival [ Time Frame: From date of treatment beginning until the date of death from any cause, through study completion, an average of 1 months ]
    Time from treatment beginning until death from any cause
  • Adverse Effect [ Time Frame: Through study completion, an average of 1 months ]
    Incidence of Treatment-related adverse Events
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Regorafenib Plus PD-1 Inhibitor in Patients With Colorectal Cancer
Official Title  ICMJE The Efficacy and Safety of Regorafenib Plus PD-1 Inhibitor as Third-line Therapy in Advanced Colorectal Cancer Patients
Brief Summary This study is intended to evaluate efficacy and safety of the combination of regorafenib and nivolumab as third-line or later therapy in patients with microsatellite stable (MSS) colorectal cancer (CRC).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Colorectal Cancer
  • Immunotherapy
Intervention  ICMJE Drug: Regorafenib and PD-1 inhibitor
All Colorectal cancer patients received regorafenib (80mg qd d1-d21,q4w) and PD-1 inhibitor. The patients could receive one type of PD-1 inhibitors according to oneself circumstance consideration including nivolumab (3mg/kg, ivgtt, q2w), Carelizumab (200mg, ivgtt, q3w), Sintilimab (200mg, ivgtt, q3w), Toripalimab(240mg ivgtt, q3w).
Study Arms  ICMJE Experimental: Immunotherapy Combination treatment
All colorectal cancer patients received regorafenib plus PD-1 inhibitor
Intervention: Drug: Regorafenib and PD-1 inhibitor
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 7, 2019)
120
Original Estimated Enrollment  ICMJE
 (submitted: September 28, 2019)
40
Estimated Study Completion Date  ICMJE August 31, 2021
Estimated Primary Completion Date August 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Advanced Colorectal Cancer diagnosed histologically;
  • Patients with microsatellite stable (MSS)
  • Patients have no any standard choice after multiple line of therapy( ≥ 2 lines);
  • Expected survival ≥ 3 month;
  • ECOG / PS score: 0-2, and the main organ function to meet the following criteria: HB ≥ 90g / L, ANC ≥ 1.5 × 109 / L, PLT ≥ 80 × 109 / L,BIL <1.5 times the upper limit of normal (ULN); Liver ALT and AST <2.5 × ULN and if liver metastases, ALT and AST <5 × ULN; Serum Cr ≤ 1 × ULN, endogenous creatinine clearance ≥50ml/min

Exclusion Criteria:

  • Patient still has standard treatment therapy based on NCCN guidance;
  • Patient can not comply with research program requirements or follow-up;
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04110093
Other Study ID Numbers  ICMJE CZ-REGONIVO
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yuan-Sheng Zang, Shanghai Changzheng Hospital
Study Sponsor  ICMJE Shanghai Changzheng Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Shanghai Changzheng Hospital
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP