Efficacy and Safety of Retlirafusp Alfa Plus Bevacizumab and Chemotherapy With or Without Short-Course Radiotherapy in Patients With CRCLM

NCT07728019 | Recruiting Phase 2

• 1 other identifier: MA-CRC-II-023
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Efficacy and safety of retlirafusp alfa combined with bevacizumab and chemotherapy with or without short-course radiotherapy in conversion therapy for advanced colorectal cancer liver metastases: an exploratory study.

Conditions

CRC (Colorectal Cancer)

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival

  Assessed by the investigator using RECIST v1.1, defined as the time from the start of study treatment to disease progression, or relapse after resection of liver metastases, or death due to any cause.

  Each follow up visit, assessed up to 60 months

Secondary Outcomes (5)

• Overall Response Rate

  assessed up to 12 months

• R0 Resection Rate

  Each follow up visit, assessed up to 12 month

• Pathological complete response rate (pCR)

  2 years after last patient in study

• Overall Survival

  Each follow up visit, assessed up to 60 months

• Toxicity (AE)

  2 years after last patient in study

Study Arms (2)

SCRT combined with Retlirafusp Alfa Plus Bevacizumab and Chemotherapy

EXPERIMENTAL

Total dose 25 Gy delivered in 5 fractions (5 Gy per fraction, once daily over 5 consecutive days). Retlirafusp alfa plus bevacizumab and capox will recive every 3 weeks, initiated 1 week after radiontherapy completion.

Radiation: SCRT; Drug: Retlirafusp alfa Injection; Drug: Bevacizumab; Drug: CAPOX

Retlirafusp Alfa combined with Bevacizumab and Chemotherapy

EXPERIMENTAL

Retlirafusp alfa plus bevacizumab and capox will recive every 3 weeks

Drug: Retlirafusp alfa Injection; Drug: Bevacizumab; Drug: CAPOX

Interventions

SCRT RADIATION

short-course radiotherapy

SCRT combined with Retlirafusp Alfa Plus Bevacizumab and Chemotherapy

Retlirafusp alfa Injection DRUG

Retlirafusp alfa :1800 mg via intravenous infusion every 3 weeks (q3w)

Retlirafusp Alfa combined with Bevacizumab and Chemotherapy; SCRT combined with Retlirafusp Alfa Plus Bevacizumab and Chemotherapy

Bevacizumab DRUG

Bevacizumab: 7.5 mg/kg, D1, IV, Q3W

Retlirafusp Alfa combined with Bevacizumab and Chemotherapy; SCRT combined with Retlirafusp Alfa Plus Bevacizumab and Chemotherapy

CAPOX DRUG

CAPOX:oxaliplatin 130 mg/m²,IV, D1 ; Capecitabine: 1000 mg/m² orally twice daily, Days 1-14; Cycle duration: 3 weeks per cycle

Retlirafusp Alfa combined with Bevacizumab and Chemotherapy; SCRT combined with Retlirafusp Alfa Plus Bevacizumab and Chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provide signed written informed consent and voluntarily agree to participate in this study.
• Age ≥ 18 years and ≤ 75 years.
• Histologically confirmed colorectal adenocarcinoma.
• Liver metastasis confirmed by imaging or pathology.
• Have not received any prior anti-cancer therapy.
• At least one measurable lesion according to RECIST v1.1.
• pMMR/MSS status confirmed by a local testing center, or unknown status.
• Be able to swallow tablets.
• ECOG PS 0-1
• Have no contraindications for surgery.
• Have adequate major organ function.

You may not qualify if:

• Have a history of allergy to monoclonal antibodies, any component of retlirafusp alfa, bevacizumab, capecitabine, oxaliplatin, or other platinum-based agents.
• Have previously received or are currently receiving any of the following treatments:
• Any anti-tumor therapy including surgery, radiotherapy, chemotherapy, targeted therapy, or immunotherapy.
• Use of immunosuppressive agents or systemic corticosteroids for immunosuppressive purposes within 2 weeks prior to the first dose of study drug (at a dose \> 10 mg/day prednisone or equivalent). Inhaled or topical corticosteroids, and adrenal replacement therapy at doses \> 10 mg/day prednisone or equivalent, are permitted in the absence of active autoimmune disease.
• Receipt of live attenuated vaccine within 4 weeks prior to the first dose of study drug.
• Major surgery or severe trauma within 4 weeks prior to the first dose of study drug.
• Have a history of immunodeficiency, including HIV-positive test, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation or allogeneic bone marrow transplantation.
• Have poorly controlled cardiac symptoms or diseases, including but not limited to: (1) heart failure of New York Heart Association (NYHA) class ≥ II; (2) unstable angina; (3) myocardial infarction within 1 year; (4) clinically significant supraventricular or ventricular arrhythmias that have not been clinically intervened or remain poorly controlled after intervention.
• Have experienced a severe infection (CTCAE grade \> 2) within 4 weeks prior to the first dose of study drug, such as severe pneumonia requiring hospitalization, bacteremia, or infectious complications; or have evidence of active pulmonary inflammation on baseline chest imaging, or have signs/symptoms of infection or require oral or intravenous antibiotic therapy within 14 days prior to the first dose of study drug (except for prophylactic antibiotic use).
• Have active pulmonary tuberculosis infection by history or CT examination, or a history of active pulmonary tuberculosis infection within 1 year prior to enrollment, or a history of active pulmonary tuberculosis infection \> 1 year ago without adequate treatment.
• Have hepatitis B (HBV DNA ≥ 2000 IU/mL or ≥ 10⁴ copies/mL), or hepatitis C (positive anti-HCV antibody and HCV RNA above the lower limit of detection of the assay).
• Are pregnant or breastfeeding.

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead
• Jiangsu HengRui Medicine Co., Ltd.: collaborator

Study Sites (1)

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

Wuhan, Hubei, 430022, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Tao Zhang, MD

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

  PRINCIPAL INVESTIGATOR

• Kaixiong Tao, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhenyu Lin, MD

CONTACT

027-83262683; whxhlzy@hust.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 22, 2026
• First Posted: July 27, 2026
• Study Start: July 30, 2026
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): December 31, 2031
• Last Updated: September 22, 2026

Record last verified: 2026-09

Locations

CN (1)