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PD-1 Inhibitor Combined With Bevacizumab and FOLFIRI Regimen in the Second-line Treatment of Advanced Colorectal Cancer

Primary Purpose

MSI-H Advanced Colorectal Cancer

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Pembrolizumab (PD-1 Inhibitor) Combined With Bevacizumab and FOLFIRI Regimen
Sponsored by
Tianjin Medical University Cancer Institute and Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for MSI-H Advanced Colorectal Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 1. Recurrent or metastatic unresectable colorectal adenocarcinoma confirmed by histology and/or cytology; 2. First-line oxaliplatin-containing chemotherapy has disease progression during chemotherapy or within 6 months after chemotherapy; 3. MSI-H patients confirmed by pathology, MSH2(-) or MSH6(-), for MLH1(-) or PMS2(-) patients need PCR confirmation; 4. According to the RECIST 1.1 standard, there is at least one measurable lesion; 5. Sufficient bone marrow function, liver and kidney function; 6. age greater than 18 years old, less than or equal to 75 years old; 7. ECOG score 0 or 1; expected survival time greater than 3 months; signed informed consent.

Exclusion Criteria:

  • 1. For patients who have been treated with PD-1 in the first-line treatment, bevacizumab is allowed in the first-line treatment; 2. Other malignant tumors have been diagnosed within 5 years before the first use of the study drug, except for effectively treated skin basal cell carcinoma, skin squamous cell carcinoma, and/or effectively resected in situ cervical cancer and/or breast cancer; 3. Suffer from any active autoimmune disease or have a history of autoimmune disease; 4. Are suffering from an active infection that requires systemic treatment; 5. The HIV test result is positive; 6. Known to be allergic to certain components of the research drug or similar drugs; 7. Use clinical investigational drugs within 4 weeks before the start of study administration; 8. Major surgery has been performed within 4 weeks before the start of the study administration and has not fully recovered; 9. The patient has a bleeding disorder, and the investigator judges that there is a risk of hemorrhage; 10. Uncontrolled cardiac clinical symptoms or disease heart function, such as severe arrhythmia, uncontrollable hypertension; 11. According to the judgment of the investigator, the subject has other factors that may cause him to be forced to suspend the study.

Sites / Locations

  • Tianjin Medical University Cancer Institute & HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experiment Group

Arm Description

Outcomes

Primary Outcome Measures

Objective response rate

Secondary Outcome Measures

Disease Control Rate
Progression-free survival
Overall survival
Adverse Events

Full Information

First Posted
June 21, 2021
Last Updated
September 3, 2021
Sponsor
Tianjin Medical University Cancer Institute and Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05035381
Brief Title
PD-1 Inhibitor Combined With Bevacizumab and FOLFIRI Regimen in the Second-line Treatment of Advanced Colorectal Cancer
Official Title
Phase II Clinical Study on Efficacy and Safety of PD-1 Inhibitor Combined With Bevacizumab and FOLFIRI Regimen in the Second-line Treatment of Unresectable Recurrent or Metastatic MSI-H Colorectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tianjin Medical University Cancer Institute and Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
MSI-H is a biomarker for solid tumors benefiting from immunotherapy. Recent clinical studies have confirmed that PD-1 inhibitors have a good effect on MSI-H advanced colorectal cancer for first- or second-line treatment. The overall effective rate is 30% to 40%. However, about 30% of patients are resistant to PD-1 inhibitors. Whether PD-1 inhibitors and existing chemotherapeutics and anti-vascular drugs have synergistic effects is worth studying. This study is a phase II prospective clinical study of PD-1 inhibitor combined with bevacizumab and FOLFIRI regimen in the second-line treatment of unresectable recurrent or metastatic MSI-H colorectal cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
MSI-H Advanced Colorectal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experiment Group
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Pembrolizumab (PD-1 Inhibitor) Combined With Bevacizumab and FOLFIRI Regimen
Other Intervention Name(s)
Bevacizumab, Irinotecan, Fluorouracil, Leucovorin
Intervention Description
MSI-H colorectal cancer, recurrence and metastasis within 1 year after surgery, or failure of first-line oxaliplatin and fluorouracil chemotherapy for advanced colorectal cancer, PD-1 inhibitors combined with bevacizumab and FOLFIRI regimen
Primary Outcome Measure Information:
Title
Objective response rate
Time Frame
Up to one year
Secondary Outcome Measure Information:
Title
Disease Control Rate
Time Frame
Up to 2 years
Title
Progression-free survival
Time Frame
up to 2 years
Title
Overall survival
Time Frame
up to 3 years
Title
Adverse Events
Time Frame
up to one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1. Recurrent or metastatic unresectable colorectal adenocarcinoma confirmed by histology and/or cytology; 2. First-line oxaliplatin-containing chemotherapy has disease progression during chemotherapy or within 6 months after chemotherapy; 3. MSI-H patients confirmed by pathology, MSH2(-) or MSH6(-), for MLH1(-) or PMS2(-) patients need PCR confirmation; 4. According to the RECIST 1.1 standard, there is at least one measurable lesion; 5. Sufficient bone marrow function, liver and kidney function; 6. age greater than 18 years old, less than or equal to 75 years old; 7. ECOG score 0 or 1; expected survival time greater than 3 months; signed informed consent. Exclusion Criteria: 1. For patients who have been treated with PD-1 in the first-line treatment, bevacizumab is allowed in the first-line treatment; 2. Other malignant tumors have been diagnosed within 5 years before the first use of the study drug, except for effectively treated skin basal cell carcinoma, skin squamous cell carcinoma, and/or effectively resected in situ cervical cancer and/or breast cancer; 3. Suffer from any active autoimmune disease or have a history of autoimmune disease; 4. Are suffering from an active infection that requires systemic treatment; 5. The HIV test result is positive; 6. Known to be allergic to certain components of the research drug or similar drugs; 7. Use clinical investigational drugs within 4 weeks before the start of study administration; 8. Major surgery has been performed within 4 weeks before the start of the study administration and has not fully recovered; 9. The patient has a bleeding disorder, and the investigator judges that there is a risk of hemorrhage; 10. Uncontrolled cardiac clinical symptoms or disease heart function, such as severe arrhythmia, uncontrollable hypertension; 11. According to the judgment of the investigator, the subject has other factors that may cause him to be forced to suspend the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hongli Li, Dr.
Phone
86-22-23340123
Ext
1051
Email
hongli@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Tao Ning, Dr.
Phone
86-22-23340123
Ext
1051
Email
ningtao37@163.com
Facility Information:
Facility Name
Tianjin Medical University Cancer Institute & Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dongyan Cheng, Dr
First Name & Middle Initial & Last Name & Degree
Hongli Li, Dr.
First Name & Middle Initial & Last Name & Degree
Yi Ba, Dr.

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

PD-1 Inhibitor Combined With Bevacizumab and FOLFIRI Regimen in the Second-line Treatment of Advanced Colorectal Cancer

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