Actively Recruiting
A Series of Neoadjuvant Chemoradiotherapy Combined With Immunotherapy for Locally Advanced Rectal Cancer
Led by Beijing Friendship Hospital · Updated on 2026-01-13
375
Participants Needed
2
Research Sites
141 weeks
Total Duration
On this page
Sponsors
B
Beijing Friendship Hospital
Lead Sponsor
B
Beijing Chao Yang Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to compare the efficacy and safety of neoadjuvant chemoradiotherapy combined with tirelizumab compared with neoadjuvant chemoradiotherapy alone for neoadjuvant therapy in patients with locally advanced rectal cancer. The main questions it aims to answer are: To evaluate the efficacy and safety of neoadjuvant chemoradiotherapy combined with tirelizumab compared with neoadjuvant chemoradiotherapy alone for neoadjuvant therapy in patients with locally advanced rectal cancer To assess rectal or anal retention as well as quality of life. Participants will receive a long course of NCRT (50 Gy / 25f, capecitabine 850-1000 mg / m2, BID, PO, D1-D5, QW) within the first 5 weeks. In regard to tumor immunotherapy, enrolled patients will receive tislelizumab (200 mg, iv) on the first day at week 2,5, and 8 after initiation of radiotherapy. Thereafter, patients will be treated with two 14-day cycles of the CAPOX（Q 3 w; D1 oxaliplatin, 130mg/m2,iv.gtt; D1-D14, capecitabine, 850-1000mg / m2, BID, PO）regimen. Two CAOPX regimens were treated one week apart.
CONDITIONS
Official Title
A Series of Neoadjuvant Chemoradiotherapy Combined With Immunotherapy for Locally Advanced Rectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed a written informed consent form and agreed to participate in the study
- Age between 18 and 75 years, male or female
- Pathologically confirmed rectal adenocarcinoma with pMMR or MSS status
- Clinical stage T1-2N1-2M0 or T3N0-2M0 without mesorectal fascia or lateral lymph node involvement based on MRI
- Tumor located at least 10 cm from the anal margin
- Planned surgical resection
- Able to swallow tablets normally
- ECOG performance status of 0 or 1
- No prior anti-tumor treatment for rectal cancer
- Plan to undergo surgery after completing neoadjuvant therapy
- No contraindications to surgery
- Normal main organ function
You will not qualify if you...
- History of allergy to monoclonal antibodies, tislelizumab components, or capecitabine
- Previous tumor-specific surgery, radiotherapy, chemotherapy, targeted therapy, or immunotherapy
- Use of immunosuppressive drugs or systemic hormones above specified doses within 2 weeks before study drug
- Use of live attenuated vaccines within 4 weeks before study drug
- Major surgery or severe trauma within 4 weeks before study drug
- Active autoimmune diseases including but not limited to interstitial pneumonia, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, thyroid disorders, psoriasis, or asthma requiring medical intervention
- History of immunodeficiency, HIV positive, or history of organ/bone marrow transplantation
- Uncontrolled cardiac disease or symptoms including heart failure NYHA II or higher, unstable angina, recent myocardial infarction, or arrhythmias
- Severe infection within 4 weeks before study drug or active lung inflammation
- Active or recent tuberculosis infection
- Active hepatitis B or hepatitis C infection
- Diagnosis of other malignancies within 5 years except low-risk treated skin cancers
- Pregnancy or breastfeeding
- Other serious illnesses or factors affecting safety or compliance as judged by investigator
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100050
Actively Recruiting
2
Beijing Friendship Hospital
Beijing, Beijing Municipality, China, 100050
Actively Recruiting
Research Team
Z
Zhongtao Zhang, MD
CONTACT
H
Hongwei Yao
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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