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

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

Treatments tested in this trial

Serplulimab
Fruquintinib
mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU)

Treatment groups

42 Participants

are divided into 1 treatment group

Locations

Fudan University Shanghai Cancer Center ShanghaiXuhui, China

Sponsors and collaborators

Ye Xu

Lead sponsor

Fudan University

Sponsor institution

Source ClinicalTrials.gov