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SBRT Combined With Fruquintinib Plus PD-1/CTLA-4 Antibody for Third-line Treatment in mCRC

Primary Purpose

Metastatic Colorectal Cancer

Status
Not yet recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
SBRT, Fruquintinib, Cadonilimab
Sponsored by
Wuhan Union Hospital, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Colorectal Cancer

Eligibility Criteria

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

Inclusion Criteria: Patients must have biopsy proven unresectable MCRC. Patients must have received first-line and second-line chemotherapy, and approved a progressive disease. Age ≥ 18 years Patients must have measurable disease at baseline. Patients can have up to only 5 discrete active extracranial lesions (≤3 in the liver and ≤3 in the lung) identified by position-emission tomography (PET) scan and also seen on correlative plain film, CT scan, or MRI within 8 weeks prior to the initiation of radiotherapy. Patients who previously received radiotherapy to the primary site will be ineligible if there is CT evidence of disease progression within the past 3 months. Patients must have a Karnofsky Performance Scores (KPS) >60 8. Aspartate aminotransferase, alanine aminotransferase & Alkaline phosphates must be ≤ 2.5 times the upper limit of normal (ULN). Total bilirubin must be within the limit of normal. 9. Patients should have adequate bone marrow function as defined by peripheral granulocyte count of ≥1500/mm3. 10. Patients should have adequate renal function (serum creatinine ≤1.5 times the ULN). 11. Females of childbearing potential should have a negative pregnancy test. 12. Patients who would be receiving radiation for lung lesions who are known or suspected by the treating radiation oncologist to have compromised lung function must have a documented forced expiratory volume in 1 second (FEV1) ≥ 1 litre. 13. Patients must provide verbal and written informed consent to participate in the study. 14. Total bilirubin: within normal institutional limits Exclusion Criteria: Patients with either untreated brain metastases or brain metastases treated within the past three months are ineligible Patients with serious, uncontrolled, concurrent infection(s). Significant weight loss (>10%) in the prior 3 months. Treatment for other carcinomas within the last five years, except cured non-melanoma skin and treated in-situ cancers. Patients with more than 5 discrete metastatic lesions. Participation in any investigational drug study within 4 weeks preceding the start of study treatment. Unwillingness to participate or inability to comply with the protocol for the duration of the study. Patients who are pregnant. Patients with reproductive capability will need to use adequate contraception during the time of participation in the study

Sites / Locations

  • Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SBRT, Fruquintinib, Cadonilimab

Arm Description

Outcomes

Primary Outcome Measures

Progression free survival
Progression free survival

Secondary Outcome Measures

Actuarial rate in-field local control
To describe the actuarial rate in-field local control and rate of out-of-field disease progression
Toxicities
Acute toxicity was scored according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v3.0 criteria during and up to 3 months after radiotherapy. Late toxicity was graded using the Radiation Therapy Oncology Group (RTOG)/European Organisation for the Research and Treatment of Cancer (EORTC) criteria.

Full Information

First Posted
February 18, 2023
Last Updated
February 18, 2023
Sponsor
Wuhan Union Hospital, China
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1. Study Identification

Unique Protocol Identification Number
NCT05747716
Brief Title
SBRT Combined With Fruquintinib Plus PD-1/CTLA-4 Antibody for Third-line Treatment in mCRC
Official Title
SBRT Combined With Fruquintinib Plus PD-1/CTLA-4 Antibody Cadonilimab for Third-line Treatment in Metastatic Colonrectal Cancer.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 28, 2023 (Anticipated)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wuhan Union Hospital, China

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The study is a phase II clinical study. The purpose of the study is to evaluate the efficacy and safety of SBRT combined with Fruquintinib Plus PD-1/CTLA-4 Antibody for Third-line Treatment in mCRC.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic 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
44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SBRT, Fruquintinib, Cadonilimab
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
SBRT, Fruquintinib, Cadonilimab
Intervention Description
Radiation: Stereotactic body radiationtherapy (SBRT) for metastatic sites (less than 5) Fruquintinib: 5mg, po, everyday; Cadonilimab: 10mg/kg, iv, q3w
Primary Outcome Measure Information:
Title
Progression free survival
Description
Progression free survival
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Actuarial rate in-field local control
Description
To describe the actuarial rate in-field local control and rate of out-of-field disease progression
Time Frame
2 years
Title
Toxicities
Description
Acute toxicity was scored according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v3.0 criteria during and up to 3 months after radiotherapy. Late toxicity was graded using the Radiation Therapy Oncology Group (RTOG)/European Organisation for the Research and Treatment of Cancer (EORTC) criteria.
Time Frame
2 years

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: Patients must have biopsy proven unresectable MCRC. Patients must have received first-line and second-line chemotherapy, and approved a progressive disease. Age ≥ 18 years Patients must have measurable disease at baseline. Patients can have up to only 5 discrete active extracranial lesions (≤3 in the liver and ≤3 in the lung) identified by position-emission tomography (PET) scan and also seen on correlative plain film, CT scan, or MRI within 8 weeks prior to the initiation of radiotherapy. Patients who previously received radiotherapy to the primary site will be ineligible if there is CT evidence of disease progression within the past 3 months. Patients must have a Karnofsky Performance Scores (KPS) >60 8. Aspartate aminotransferase, alanine aminotransferase & Alkaline phosphates must be ≤ 2.5 times the upper limit of normal (ULN). Total bilirubin must be within the limit of normal. 9. Patients should have adequate bone marrow function as defined by peripheral granulocyte count of ≥1500/mm3. 10. Patients should have adequate renal function (serum creatinine ≤1.5 times the ULN). 11. Females of childbearing potential should have a negative pregnancy test. 12. Patients who would be receiving radiation for lung lesions who are known or suspected by the treating radiation oncologist to have compromised lung function must have a documented forced expiratory volume in 1 second (FEV1) ≥ 1 litre. 13. Patients must provide verbal and written informed consent to participate in the study. 14. Total bilirubin: within normal institutional limits Exclusion Criteria: Patients with either untreated brain metastases or brain metastases treated within the past three months are ineligible Patients with serious, uncontrolled, concurrent infection(s). Significant weight loss (>10%) in the prior 3 months. Treatment for other carcinomas within the last five years, except cured non-melanoma skin and treated in-situ cancers. Patients with more than 5 discrete metastatic lesions. Participation in any investigational drug study within 4 weeks preceding the start of study treatment. Unwillingness to participate or inability to comply with the protocol for the duration of the study. Patients who are pregnant. Patients with reproductive capability will need to use adequate contraception during the time of participation in the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhenyu Lin
Phone
02785871982
Email
whxhlzy@hust.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tao Zhang
Organizational Affiliation
Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China

12. IPD Sharing Statement

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SBRT Combined With Fruquintinib Plus PD-1/CTLA-4 Antibody for Third-line Treatment in mCRC

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