First-line serplulimab in metastatic colorectal cancer: Phase 2 results of a randomized, double-blind, phase 2/3 trial.
Zi-Xian Wang, Junjie Peng, Xinjun Liang...
https://pubmed.ncbi.nlm.nih.gov/38870931Actively Recruiting
Phase 2
Phase 3
Age: 18Years - 75Years
All Genders
ID04547166
A Randomized, Double-blind, Multicenter Phase II/III Study of Serplulimab with Bevacizumab and Chemotherapy (XELOX) Versus Placebo with Bevacizumab and Chemotherapy in First-line Treatment of Metastatic Colorectal Cancer
Led by Shanghai Henlius Biotech · Updated on 2024-10-17
568
Participants Needed
5
Research Sites
66 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the clinical effectiveness of Serplulimab (HLX10) combined with Bevacizumab and chemotherapy (XELOX) compared to a placebo combined with Bevacizumab and XELOX chemotherapy in treating patients with metastatic colorectal cancer (mCRC) who have not previously received systemic treatment for metastatic or recurrent disease. This phase II/III randomized, double-blind, multicenter study aims to assess how well these treatments work as a first-line therapy in this patient group. The study includes a safety run-in period enrolling 6-12 patients, followed by a phase II study with about 100 patients split evenly between treatment and control groups, and a larger phase III study involving approximately 568 patients across multiple countries. Participants receive either Serplulimab at a fixed 300 mg dose intravenously every three weeks plus Bevacizumab (7.5 mg/kg IV every three weeks) and XELOX chemotherapy, or placebo plus Bevacizumab and XELOX chemotherapy. The treatment period consists of 3-week cycles lasting up to two years. Participants will undergo a screening period up to 28 days before treatment, followed by treatment cycles and a follow-up phase including safety monitoring and survival checks every 12 weeks. Researchers will evaluate progression-free survival as the primary outcome, along with other measures such as overall survival, response rates, and disease control. Assessments will include tumor measurements, gene testing from tumor tissue, and monitoring of organ function and performance status throughout the study.
CONDITIONS
Brief 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
Age: 18Years - 75Years
All Genders
Eligibility Criteria
You may qualify if you...
- Histopathologically confirmed unresectable metastatic or recurrent colorectal adenocarcinoma
- Life expectancy of at least 12 weeks
- No previous systemic anti-tumor treatment for metastatic colorectal adenocarcinoma
- If previously treated with neoadjuvant or adjuvant therapy, at least 12 months have passed since last treatment before recurrence or progression
- At least one measurable lesion per RECIST v1.1 criteria, untreated locally by radiotherapy unless progression is confirmed
- Willing 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 surgical removal
- Presence of central nervous system or leptomeningeal metastases
- Radiotherapy within 6 months before study treatment initiation except palliative bone radiotherapy at least 14 days prior
- History or current lung diseases including interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonitis, or severe lung dysfunction
- Major surgery within 28 days before randomization
- Intestinal stent placement remaining in place at screening
- Uncontrolled hypertension (systolic ≥150 mmHg or diastolic ≥100 mmHg)
- History of hypertensive crisis or encephalopathy
- Significant bleeding within 1 month or blood transfusion within 2 weeks before randomization
- Long-term daily NSAID use (occasional use allowed)
- Meteorism not due to recent surgery or puncture
- Severe unhealed wounds, active ulcers, or untreated fractures
- Within 6 months prior: abdominal or tracheoesophageal fistula, gastrointestinal perforation or abscess, massive ascites requiring drainage, intestinal obstruction requiring clinical intervention, severe uncontrollable intra-abdominal inflammation, major vascular disease requiring surgery or associated with recent thrombosis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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2
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Your Study Journey
Screening
Duration - Up to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 2 years
Participants receive Serplulimab or placebo combined with Bevacizumab and XELOX chemotherapy in repeated 3-week cycles as first-line treatment for metastatic colorectal cancer.
Every 3 weeks (Day 1 of each cycle) for drug administration and assessments
Follow-up
Duration - Up to approximately 8 years after treatment (up to 100 months)
Participants are monitored for safety and survival after completing treatment, including safety follow-up and survival assessments every 12 weeks.
Visits every 12 weeks for survival follow-up
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
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Research Team
R
Ruihua Xu
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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