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Phase II Study of Serplulimab Combined with First-Line Targeted Therapy, Chemotherapy, and Radiation in Advanced Colorectal Cancer

NCT06521866 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 208

Last updated 2025-03-14

No results posted yet for this study

Summary

Study Title:

A Prospective, Randomized, Phase II, Multicenter Clinical Study of Serplulimab Combined with Targeted Therapy, Chemotherapy, and Optional Radiotherapy in Advanced Colorectal Cancer

Study Objective:

To explore the efficacy and safety of immune checkpoint inhibitor combined with targeted therapy and chemoradiotherapy in locally advanced unresectable or metastatic colorectal cancer.

Study Population:

Patients with left-sided wild-type, right-sided, or RAS-mutant advanced colorectal cancer who have not received systemic treatment.

Study Endpoints:

Progression-free survival (PFS), objective response rate (ORR), overall survival (OS), safety, and R0 resection rate.

Study Design:

Prospective, randomized Phase II clinical study.

Conditions

  • Advanced Colorectal Carcinoma
  • Immunotherapy

Interventions

DRUG

Serplulimab

IV 3 mg/kg on Day 1, q2w

DRUG

Chemotherapy

Induction therapy：Oxaliplatin: 85 mg/m² IV on Day 1 Leucovorin (LV): 400 mg/m² IV on Day 1 5-FU: 400 mg/m² IV bolus on Day 1, then 2400 mg/m² continuous IV infusion over 46-48 hours Maintenance therapy: Leucovorin (LV): 400 mg/m² IV on Day 1 5-FU: 400 mg/m² IV bolus on Day 1, then 2400 mg/m² continuous IV infusion over 46-48 hours

RADIATION

SABR

SABR: 25-60 Gy/5 Fx

DRUG

Targeted therapy

Cetuximab: 400 mg/m² IV on Day 1, then 250 mg/m² IV weekly ; Bevacizumab: 5 mg/kg IV on Day 1

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-01
Primary Completion
2026-08-01
Completion
2027-08-01

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06521866 on ClinicalTrials.gov