Phase II Study of Serplulimab Combined with First-Line Targeted Therapy, Chemotherapy, and Radiation in Advanced Colorectal Cancer
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
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
Treatments tested in this trial
- Serplulimab
- Chemotherapy
- SABR
- Targeted therapy
Treatment groups
208 Participants
are divided into 4 treatment groupsLocations
10Fujian Cancer Hospital350000, FuzhouFujian, China
The First Affiliated Hospital of Xiamen University361000, XiamenFujian, China
Lanzhou Military Region General Hospital730000, LanzhouGansu, China
The First Affiliated Hospital of Zhengzhou University450000, ZhengzhouHenan, China
Sponsors and collaborators
Fudan University
Lead sponsor
Source ClinicalTrials.gov