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FOLFOX Chemotherapy Combined With Fruquintinib and Serplulimab as First-Line Conversion Therapy for Initially Unresectable pMMR/MSS Colorectal Cancer

ConditionsColorectal Cancer (Locally Advanced or Metastatic)Colorectal Cancer Microsatellite Stable (MSS)
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-75
SponsorYe Xu

About this trial

To evaluate the efficacy and safety of immune checkpoint inhibitor-based combination therapy with targeted therapy and chemotherapy in patients with locally advanced unresectable or metastatic colorectal cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-75 years;

Histologically confirmed adenocarcinoma of colorectal cancer, initially unresectable locally advanced or metastatic/recurrent disease;

Expected survival ≥12 weeks;

No prior systemic antitumor therapy for colorectal cancer;

Disqualifiers

Prior immune checkpoint inhibitor therapy;

CNS or leptomeningeal metastases;

Uncontrolled cardiovascular disease or hypertension;

Active autoimmune disease requiring systemic therapy;

Trial design

Design model

Single group

Treatments tested in this trial

  • Serplulimab

    Drug

    Serplulimab: 200 mg IV Day 1, q2w

  • Fruquintinib

    Drug

    Fruquintinib: 4 mg orally once daily, Days 1-21, every 4 weeks

  • mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU)

    Drug

    Oxaliplatin 85 mg/m² IV q2w Leucovorin 400 mg/m² IV q2w 5-FU 400 mg/m² IV bolus Day 1 5-FU 1200 mg/m²/day continuous IV infusion Days 2-3

Treatment groups

42 Participants
are divided into 1 treatment group
Group A: Conversion TherapyExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Conversion Rate to Surgery

Time frame
≤ 6 months
2

Objective Response Rate

Time frame
≤6 month

Secondary outcomes

1

Disease Control Rate

Time frame
6 months
2

Depth of Response

Depth of Response (DpR): defined as the maximum percentage reduction of tumor target lesions compared with baseline (pre-treatment) during the course of tumor treatment.

Time frame
6 months
3

Early Tumor Shrinkage

Early Tumor Shrinkage (ETS): defined as a predefined percentage reduction in the sum of the longest diameters of target lesions within a specified time period after the initiation of treatment.

Time frame
6 months
4

R0 Resection Rate

Time frame
6 months

Other outcomes

Sponsors and contacts

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

Ye Xu

Lead sponsor

Fudan University

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: