Actively Recruiting
Phase II Study of Serplulimab Combined with First-Line Targeted Therapy, Chemotherapy, and Radiation in Advanced Colorectal Cancer
Led by Fudan University · Updated on 2025-03-14
208
Participants Needed
10
Research Sites
126 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Phase II Study of Serplulimab Combined with First-Line Targeted Therapy, Chemotherapy, and Radiation in Advanced Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, any gender
- Histologically confirmed metastatic colorectal cancer (Stage IV) with initially unresectable metastases or refusal of surgery
- For cohorts A and B: primary tumor in distal transverse colon, descending colon, sigmoid colon, or rectum with RAS and BRAF wild-type
- For cohorts C and D: primary tumor in cecum, ascending colon, or proximal transverse colon with RAS mutant-type
- No prior standard anti-tumor therapy received
- At least one measurable tumor lesion per RECIST 1.1 criteria
- ECOG performance status of 0 or 1
- Expected survival time of at least 3 months and good organ function including specified blood counts and biochemical parameters
- Female patients of childbearing potential must have a negative pregnancy test
- Male and female patients of reproductive potential must agree to use effective contraception during the study and for 12 months after last dose
- Signed informed consent and willingness to comply with study procedures
You will not qualify if you...
- Diagnosed with other intestinal tumors such as gastrointestinal stromal tumors
- No testing done for RAS mutation status
- Resectable metastases or desire to undergo metastasectomy
- Prior systemic therapy including chemotherapy, targeted agents, or immune checkpoint inhibitors
- Uncontrolled bleeding from primary tumor or bowel obstruction
- Contraindications to immune checkpoint inhibitors
- Allergy to study drugs or their components
- Previous treatment with PD-1, PD-L1, or CTLA-4 antibodies
- Radiation therapy within 4 weeks prior to enrollment
- Previous or concurrent other malignancies except certain treated skin or cervical cancers
- Active or history of autoimmune diseases except certain stable conditions
- History of immunodeficiency or organ/bone marrow transplantation
- History of interstitial lung disease or non-infectious pneumonia
- Active tuberculosis infection or recent history without proper treatment
- Active hepatitis B or C infection
- Severe heart, lung, or kidney dysfunction
- Poorly controlled hypertension
- History of substance abuse or addiction
- Other serious medical or social conditions affecting safety or study compliance
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 10 locations
1
Fujian Cancer Hospital
Fuzhou, Fujian, China, 350000
Not Yet Recruiting
2
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China, 361000
Not Yet Recruiting
3
Lanzhou Military Region General Hospital
Lanzhou, Gansu, China, 730000
Not Yet Recruiting
4
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450000
Not Yet Recruiting
5
Huai'an Second People's Hospital
Huaian, Jiangsu, China, 223001
Not Yet Recruiting
6
Qianfoshan Hospital of Shandong Province
Jinan, Shandong, China, 250000
Not Yet Recruiting
7
Taian City Central Hospital
Taian, Shandong, China, 271000
Not Yet Recruiting
8
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200030
Actively Recruiting
9
Yunnan Cancer Hospital
Kunming, Yunnan, China, 650000
Not Yet Recruiting
10
Anyang Cancer Hospital
Anyang, China, 455000
Not Yet Recruiting
Research Team
D
Dawei Li, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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