Actively Recruiting
Short-Course Radiotherapy Followed by Neoadjuvant Chemotherapy, HLX07and Serplulimab in LARC
Led by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Updated on 2024-12-18
29
Participants Needed
3
Research Sites
123 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The study is a multicenter, open-label, phase II clinical study, and the purpose of the study is to explore the complete response rate (CR, Defined as pathological complete response (pCR) + Clinical complete response (cCR)) of patients with RAS/BRAF wild type locally advanced rectal cancer(LARC) treated with short-term radiotherapy, sequential HLX07, Serplulimab and CAPOX. A total of 29 patients were included in this study.
CONDITIONS
Official Title
Short-Course Radiotherapy Followed by Neoadjuvant Chemotherapy, HLX07and Serplulimab in LARC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients or their family members agree to participate and sign the informed consent form
- Age 18-75 years, male or female
- Histologically confirmed locally advanced rectal adenocarcinoma
- Genetic test or immunohistochemical confirmation of RAS, BRAF wild type
- Tumor inferior margin 6 10 cm from the anal verge
- Pelvic MRI shows high-risk features including cT4a or cT4b, extramural vascular infiltration, cN2 lymph node staging, mesenteric fascia involvement, or lateral lymph node enlargement
- ECOG performance status score is 0-1
- Ability to swallow pills normally
- No prior anti-tumor therapy for rectal cancer including radiotherapy, chemotherapy, or surgery
- No operative contraindications
- Laboratory tests meet specific blood counts and organ function criteria
- Willingness to use contraception if of reproductive ability
You will not qualify if you...
- History of allergy to study drugs including anti-EGFR or PD-1 antibodies, capecitabine, oxaliplatin, or other platinum drugs
- Prior or current radiotherapy, chemotherapy, or other anti-tumor treatments for tumor
- Need for corticosteroids (>10 mg prednisone equivalent) or immunosuppressive agents within 2 weeks before study drug
- Live attenuated vaccine within 4 weeks before first study drug use
- Major surgery or severe trauma within 4 weeks before first study drug use
- Active or history of autoimmune disease
- History of immunodeficiency, including HIV or organ/bone marrow transplantation
- Uncontrolled heart disease symptoms
- Severe infection within 4 weeks before first study drug use
- Active pulmonary inflammation or infection within 14 days before first study drug use
- Active pulmonary tuberculosis or history within 1 year without regular treatment
- Active hepatitis B or C infection above specified levels
- Pregnancy or breastfeeding
- Investigator judgement of unsuitability for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022
Actively Recruiting
2
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Actively Recruiting
3
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Hubei, China
Actively Recruiting
Research Team
Z
zhenyu Lin, MD
CONTACT
T
Tao Zhang, MD
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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