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

ConditionCRC (Colorectal Cancer)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Have a history of allergy to monoclonal antibodies, any component of retlirafusp alfa, bevacizumab, capecitabine, oxaliplatin, or other platinum-based agents.

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • SCRT

    Radiation

    short-course radiotherapy

  • Retlirafusp alfa Injection

    Drug

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

  • Bevacizumab

    Drug

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

  • 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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: SCRT combined with Retlirafusp Alfa Plus Bevacizumab and ChemotherapyExperimental treatment 4 interventions
Group B: Retlirafusp Alfa combined with Bevacizumab and ChemotherapyExperimental treatment 3 interventions

Trial outcomes

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.

Time frame
Each follow up visit, assessed up to 60 months

Secondary outcomes

1

Overall Response Rate

Partial response (PR) plus complete response (CR)): assessed by the investigator using RECIST v1.1 criteria

Time frame
assessed up to 12 months
2

R0 Resection Rate

Defined as the proportion of patients who achieve complete resection after treatment

Time frame
Each follow up visit, assessed up to 12 month
3

Pathological complete response rate (pCR)

Pathological complete response rate (pCR) of the resected lesions

Time frame
2 years after last patient in study
4

Overall Survival

Defined as the time from the start of study treatment to death due to any cause

Time frame
Each follow up visit, assessed up to 60 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Collaborator

Source ClinicalTrials.gov
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