Actively Recruiting
A Clinical Study to Evaluate Efficacy and Safety of Serplulimab（HLX10） Combined With Bevacizumab（HLX04) and Chemotherapy (XELOX) in Patients With Metastatic Colorectal Cancer (mCRC)
Led by Shanghai Henlius Biotech · Updated on 2024-10-17
568
Participants Needed
5
Research Sites
303 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a two-arm, randomized, double-blinded, multicenter phase III clinical study to evaluate the clinical efficacy of Serplulimab (HLX10) in Combination With Bevacizumab and Chemotherapy (XELOX) Versus Placebo in Combination With Bevacizumab and Chemotherapy (XELOX) in First-line Treatment of Patients With Metastatic Colorectal Cancer (mCRC)
CONDITIONS
Official Title
A Clinical Study to Evaluate Efficacy and Safety of Serplulimab（HLX10） Combined With Bevacizumab（HLX04) and Chemotherapy (XELOX) in Patients With Metastatic Colorectal Cancer (mCRC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histopathologically confirmed unresectable metastatic or recurrent colorectal adenocarcinoma
- Life expectancy of at least 12 weeks
- No prior systemic anti-tumor treatment for metastatic colorectal adenocarcinoma
- If previously treated with neoadjuvant or adjuvant therapy, disease recurrence or progression occurred more than 12 months after last treatment
- At least one measurable lesion per RECIST v1.1, not previously treated with local radiotherapy unless progression is confirmed
- Agree to provide preserved tumor tissue or undergo biopsy for gene testing
- ECOG performance status of 0 or 1 within 7 days before first study drug dose
- Adequate major organ function
You will not qualify if you...
- Confirmed MSI-H colorectal cancer by gene testing
- Oligometastatic liver disease with potential for resection
- Presence of central nervous system or leptomeningeal metastases
- Radiotherapy within 6 months before study treatment (except palliative for bone disorders at least 14 days prior)
- History or current interstitial pneumonia, pneumoniosis, radiation pneumonitis, drug-related pneumonitis, severe pulmonary dysfunction
- Major surgery within 28 days before randomization
- Intestinal stent implantation remaining at screening
- Uncontrolled hypertension despite treatment (systolic ≥150 mmHg or diastolic ≥100 mmHg)
- History of hypertensive crisis or encephalopathy
- Significant hemorrhage within 1 month before randomization or blood transfusion within 2 weeks
- Long-term daily use of NSAIDs (occasional use allowed)
- Meteorism not related to recent surgery or puncture
- Severe unhealed wounds, active ulcers, or untreated fractures
- Severe abdominal or tracheoesophageal fistula, gastrointestinal perforation, or abscess requiring intervention
- Intestinal obstruction or recent symptoms requiring parenteral support within 2 months unless improved
- Severe intra-abdominal inflammation needing intervention
- Major vascular disease such as aortic aneurysm requiring repair or recent peripheral artery thrombosis
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 5 locations
1
Center for Cancer Prevention and Treatment of Sun Yat-sen University
Guangzhou, Guangdong, China, 510075
Actively Recruiting
2
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022
Actively Recruiting
3
Linyi Cancer Hospital
Linyi, China
Actively Recruiting
4
Fudan University Affiliated Oncology Hospital
Shanghai, China
Actively Recruiting
5
National Cancer Center
Kashiwa, Japan
Not Yet Recruiting
Research Team
R
Ruihua Xu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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