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

ConditionsAdvanced Colorectal CarcinomaImmunotherapy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorFudan University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years, any gender;

Histologically confirmed metastatic colorectal cancer (Stage IV, UICC), with initially unresectable metastases or refusal of surgery;

Primary tumor located in the distal transverse colon, descending colon, sigmoid colon, and rectum, and RAS (KRAS and NRAS) and BRAF wild-type (Cohorts A and B);

Primary tumor located in the cecum, ascending colon, and proximal transverse colon, and RAS (KRAS and NRAS) mutant-type (Cohorts C and D);

Disqualifiers

Pathologically diagnosed with other intestinal tumors, such as gastrointestinal stromal tumors;

No testing for RAS mutation status;

Resectable metastases or patients wishing to undergo metastasectomy;

Prior systemic therapy. Systemic therapy includes all of the following: chemotherapy agents such as fluoropyrimidines, irinotecan, and oxaliplatin, VEGF monoclonal antibodies (e.g., bevacizumab), EGFR monoclonal antibodies (cetuximab or panitumumab), small molecule TKIs, immune checkpoint inhibitors, etc.;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Serplulimab

    Drug

    IV 3 mg/kg on Day 1, q2w

  • Chemotherapy

    Drug

    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

  • SABR

    Radiation

    SABR: 25-60 Gy/5 Fx

  • Targeted therapy

    Drug

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

Treatment groups

208 Participants
are divided into 4 treatment groups
Group A: Group AExperimental treatment 3 interventions
Group B: Group BExperimental treatment 4 interventions
Group C: Group CExperimental treatment 3 interventions
Group D: Group DExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

PFS

Progression Free Survival

Time frame
2 year

Secondary outcomes

1

OS

Overall Survial

Time frame
2 year
2

ORR

Objective Response Rate

Time frame
2 year
3

Incidence of Side Effect

Side Effect

Time frame
2 year

Other outcomes

Sponsors and contacts

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

Fudan University

Lead sponsor

Source ClinicalTrials.gov
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