RecruitingPhase 2NCT06521866

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

A Prospective, Randomized, Phase II, Multicenter Clinical Study of Serplulimab Combined with First-Line Targeted Therapy and Chemotherapy with or Without Radiation in the First-Line Treatment of Advanced Colorectal Cancer


Sponsor

Fudan University

Enrollment

208 participants

Start Date

Mar 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a combination of immunotherapy (serplulimab, a PD-1 blocker) with chemotherapy and radiation therapy as a first-line treatment for people with advanced (metastatic) colorectal cancer, targeting specific tumor types based on their genetic profile. **You may be eligible if...** - You are 18 or older with confirmed Stage IV colorectal cancer - You have not yet received treatment for your metastatic cancer - Your cancer is in the left side of the colon or rectum and is RAS/BRAF wild-type (no mutations), OR it is in the right side/ascending colon with RAS mutations - You have at least one measurable tumor on imaging - You are in good general health (ECOG 0–1) with a life expectancy of at least 3 months - Your blood counts, liver, kidney, and thyroid function are within acceptable ranges **You may NOT be eligible if...** - You have a different type of colon tumor (e.g., gastrointestinal stromal tumor) - Your metastases are surgically removable and you want surgery - You have previously received systemic cancer treatment - You have active autoimmune disease or are on immunosuppressant medications Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSerplulimab

IV 3 mg/kg on Day 1, q2w

DRUGChemotherapy

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

RADIATIONSABR

SABR: 25-60 Gy/5 Fx

DRUGTargeted therapy

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


Locations(10)

Fujian Cancer Hospital

Fuzhou, Fujian, China

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

Lanzhou Military Region General Hospital

Lanzhou, Gansu, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Huai'an Second People's Hospital

Huaian, Jiangsu, China

Qianfoshan Hospital of Shandong Province

Jinan, Shandong, China

Taian City Central Hospital

Taian, Shandong, China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Yunnan Cancer Hospital

Kunming, Yunnan, China

Anyang Cancer Hospital

Anyang, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06521866


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