Actively Recruiting
Safety and Efficacy Study of JS207 With or Without JS015 Plus Chemotherapy (XELOX) for Advanced Colorectal Cancer
Led by Shanghai Junshi Bioscience Co., Ltd. · Updated on 2025-06-24
60
Participants Needed
2
Research Sites
11 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of JS207 with or without JS015 combined with chemotherapy (XELOX) as a first treatment for advanced colorectal cancer with MSS/pMMR status. This open-label, multicenter Phase II trial divides participants into two groups: one receiving JS207 plus XELOX, and the other receiving JS207, JS015, and XELOX. The study aims to better understand treatment options for this specific type of colorectal cancer. Participants receive JS207 every three weeks in 21-day cycles. In one group, JS207 is combined with XELOX chemotherapy, which includes oral Capecitabine twice daily for 14 days and intravenous Oxaliplatin on day one of each cycle. In the other group, JS207 is combined with JS015 and XELOX following the same dosing schedule. The study monitors these treatments over time to assess their safety and how well they work. During the study, participants will be closely monitored for side effects and treatment reactions, with assessments including tumor response evaluations based on RECIST 1.1 criteria. Researchers will track outcomes such as dose-limiting toxicity, adverse events, objective response rate, progression-free survival, overall survival, and immune response over a two-year period. Participants will also undergo regular evaluations of organ function and overall health to ensure safety and treatment adherence throughout the trial.
CONDITIONS
Brief 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, male or female
- Diagnosed with colorectal or rectal adenocarcinoma, stage IV MSS/pMMR, no prior systemic treatment for advanced disease
- ECOG performance status 0 or 1
- Estimated survival of at least 12 weeks
- At least one measurable lesion by RECIST v1.1
- Good organ function
- Agree to use effective contraception during and 6 months after treatment if of childbearing potential
- Voluntary participation with informed consent and good compliance
You will not qualify if you...
- Prior PD-1, PD-L1, or DKK1 inhibitor therapy (for cohort 2)
- Major surgery or radiotherapy within 28 days before first dose; minor surgery within 7 days
- Recent use of high-dose antiplatelet or anticoagulant therapy
- Recent systemic corticosteroids or immunosuppressants beyond allowed doses
- Live vaccine within 28 days before first dose or planned during study
- Unresolved toxicity from prior cancer treatments
- Recent digestive tract complications or active ulcerative disease
- Clinically significant pleural, abdominal, or pericardial effusions
- History of interstitial lung disease or active pneumonia
- Severe wounds, ulcers, or untreated fractures
- Bleeding disorders or recent significant bleeding
- Poorly controlled hypertension or severe cardiovascular/cerebrovascular disease
- Active central nervous system metastasis, except stable brain metastases under conditions
- Recent severe infections or active infection requiring treatment
- Active tuberculosis, hepatitis B or C, or HIV infection
- History of immunodeficiency or organ transplantation
- Active autoimmune diseases requiring systemic treatment within 2 years
- History of other primary malignancies within 5 years except certain treated skin cancers
- Other serious illnesses or lab abnormalities affecting safety or study compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - Repeated 21-day cycles until disease progression or discontinuation
Participants receive JS207 with or without JS015 in combination with chemotherapy consisting of Capecitabine and Oxaliplatin in repeated 21-day cycles.
Visits every 3 weeks for treatment administration
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
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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