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

Metastatic Colorectal Cancer Clinical Trial

Official title:

SBRT Combined With Fruquintinib Plus PD-1/CTLA-4 Antibody Cadonilimab for Third-line Treatment in Metastatic Colonrectal Cancer.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05747716
• Other study ID #: MCRC-3
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: February 28, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: February 2023
• Source: Wuhan Union Hospital, China
• Contact: Zhenyu Lin
• Phone: 02785871982
• Email: whxhlzy[@]hust.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 44
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

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:

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

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Intervention

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

Locations

Country	Name	City	State
China	Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Wuhan Union Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival	Progression free survival	2 years
Secondary	Actuarial rate in-field local control	To describe the actuarial rate in-field local control and rate of out-of-field disease progression	2 years
Secondary	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.	2 years