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

• Sponsor: Wuhan Union Hospital, China (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05747716
• Collaborator: (none)
• Enrollment: 44
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 46.1
• Patients Per Site Per Month: 1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Metastatic Colorectal Cancer	Drug: SBRT, Fruquintinib, Cadonilimab	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 44 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: SBRT Combined With Fruquintinib Plus PD-1/CTLA-4 Antibody Cadonilimab for Third-line Treatment in Metastatic Colonrectal Cancer.
• Anticipated Study Start Date: Feb 28, 2023
• Anticipated Primary Completion Date: Dec 31, 2026
• Anticipated Study Completion Date: Dec 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SBRT, Fruquintinib, Cadonilimab	Drug: SBRT, Fruquintinib, Cadonilimab; Radiation: Stereotactic body radiationtherapy (SBRT) for metastatic sites (less than 5) Fruquintinib: 5mg, po, everyday; Cadonilimab: 10mg/kg, iv, q3w

Outcome Measures

Primary Outcome Measures

1. Progression free survival [2 years]

   Progression free survival

Secondary Outcome Measures

1. Actuarial rate in-field local control [2 years]

   To describe the actuarial rate in-field local control and rate of out-of-field disease progression

2. Toxicities [2 years]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Patients must have biopsy proven unresectable MCRC.

2. Patients must have received first-line and second-line chemotherapy, and approved a progressive disease.

3. Age ≥ 18 years

4. Patients must have measurable disease at baseline.

5. 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.

6. 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.

7. 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.

8. 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.

9. Patients must provide verbal and written informed consent to participate in the study.

10. Total bilirubin: within normal institutional limits

Exclusion Criteria:

1. Patients with either untreated brain metastases or brain metastases treated within the past three months are ineligible

2. Patients with serious, uncontrolled, concurrent infection(s).

3. Significant weight loss (>10%) in the prior 3 months.

4. Treatment for other carcinomas within the last five years, except cured non-melanoma skin and treated in-situ cancers.

5. Patients with more than 5 discrete metastatic lesions.

6. Participation in any investigational drug study within 4 weeks preceding the start of study treatment.

7. Unwillingness to participate or inability to comply with the protocol for the duration of the study.

8. Patients who are pregnant. Patients with reproductive capability will need to use adequate contraception during the time of participation in the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei	China	430022

Sponsors and Collaborators

• Wuhan Union Hospital, China

Investigators

• Principal Investigator: Tao Zhang, Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Wuhan Union Hospital, China
• ClinicalTrials.gov Identifier: NCT05747716
• Other Study ID Numbers: MCRC-3
• First Posted: Feb 28, 2023
• Last Update Posted: Feb 28, 2023
• Last Verified: Feb 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Colorectal Neoplasms

Study Results

No Results Posted as of Feb 28, 2023