Actively Recruiting
A Phase 2 Study Evaluating the Safety and Efficacy of JS207 With or Without JS015 in Combination With Chemotherapy in Patients With Colorectal Cancer
Led by Shanghai Junshi Bioscience Co., Ltd. · Updated on 2025-06-24
60
Participants Needed
2
Research Sites
94 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is an open label, multicenter Phase II clinical trial aimed at evaluating the safety and efficacy of JS207 with or without JS015 in combination with chemotherapy (XELOX) as a first-line treatment for advanced colorectal cancer with MSS/pMMR. The study was divided into two cohorts: Cohort 1 was JS207 combined with XELOX, and Cohort 2 was JS207 combined with JS015 and XELOX.
CONDITIONS
Official Title
A Phase 2 Study Evaluating the Safety and Efficacy of JS207 With or Without JS015 in Combination With Chemotherapy in Patients With Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 75 years at consent
- Diagnosed with colorectal or rectal adenocarcinoma, stage IV MSS/pMMR
- No prior systemic anti-tumor therapy for advanced disease; previous neoadjuvant or adjuvant therapy allowed if relapse/progression occurred after 12 months
- ECOG performance status 0 or 1
- Estimated survival of at least 12 weeks
- At least one measurable lesion per RECIST v1.1
- Good organ function
- Fertile participants agree to effective contraception during study and for 6 months after last treatment; females with fertility must have negative pregnancy test and be non-lactating
- Voluntary participation with signed informed consent and good compliance
You will not qualify if you...
- Prior treatment with PD-1, PD-L1, or DKK1 inhibitors (for cohort 2)
- Major surgery or radiotherapy within 28 days before starting study treatment; minor surgery within 7 days before study start
- Use of antiplatelet or therapeutic anticoagulant therapy within 14 days before study treatment
- Recent systemic corticosteroid or immunosuppressant use exceeding allowed doses
- Live or attenuated vaccine within 28 days before treatment or planned during study
- Unresolved toxicities from prior anti-tumor treatments above specified levels
- Recent digestive tract complications such as perforation, fistula, abscess, or ulcers within 6 months
- Symptomatic pleural, abdominal, or pericardial effusions requiring repeated treatment
- History or evidence of lung disease or active pneumonia
- Severe wounds, ulcers, or untreated fractures
- Significant bleeding risks or recent gastrointestinal bleeding
- Poorly controlled hypertension or significant cardiovascular/cerebrovascular diseases
- Active central nervous system metastases unless stable and treated
- Recent severe infections or active infection requiring treatment
- Active tuberculosis or hepatitis B or C infection
- History of immunodeficiency, HIV, or organ transplantation
- Active autoimmune diseases requiring systemic treatment within 2 years
- History of other primary malignancies unless treated with no active disease for over 5 years
- Other serious medical or mental conditions interfering with study participation or safety
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
2
Shanghai Oriental Hospital
Shanghai, Shanghai Municipality, China, 200120
Actively Recruiting
Research Team
C
Chengbo Jia, Master
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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