Actively Recruiting
Neoadjuvant Chemoradiotherapy Combined With Tislelizumab for Locally Advanced Rectal Cancer: Multicenter Phase II to Phase III Randomized Study
Led by Beijing Friendship Hospital · Updated on 2026-01-13
375
Participants Needed
2
Research Sites
N/A
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
Researchers are studying neoadjuvant chemoradiotherapy combined with the drug tislelizumab compared to chemoradiotherapy alone for patients with locally advanced rectal cancer. The trial aims to evaluate how effective and safe this combined treatment is, as well as its impact on rectal or anal retention and quality of life. This study includes phase II and phase III parts and is sponsored by Beijing Friendship Hospital. Participants in the experimental group will receive a long course of chemoradiotherapy over five weeks with capecitabine and radiation. They will also receive tislelizumab intravenously on the first day of weeks 2, 5, and 8 after starting radiotherapy. Following this, two 14-day cycles of the CAPOX chemotherapy regimen will be given. The control group will receive the same chemoradiotherapy and CAPOX treatment but without tislelizumab. After treatment, patients will have examinations including colonoscopy and MRI to guide further care. During the study, participants will undergo assessments such as colonoscopy and MRI about 8 to 10 weeks after radiation therapy. Researchers will monitor outcomes like complete response within 10 days after surgery or clinical complete response 13 weeks after starting radiotherapy. Safety will be evaluated by tracking adverse events during treatment and immune-related side effects after tislelizumab. The total duration depends on surgery timing and follow-up. The study uses a randomized design and single masking to compare treatments.
CONDITIONS
Brief 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 informed consent and volunteered to join the study
- Age between 18 and 75 years, male or female
- Confirmed rectal adenocarcinoma with pMMR or MSS status
- Clinical stage T1-2N1-2M0 or T3N0-2M0 by MRI, MRF and lateral lymph nodes negative
- Tumor lower margin at least 10 cm from anal margin
- Planned surgical resection
- Ability to swallow tablets normally
- ECOG performance status 0-1
- No prior anti-tumor treatment for rectal cancer
- Plan to have surgery after neoadjuvant therapy
- No contraindications to surgery
- Normal main organ function
You will not qualify if you...
- Allergy to monoclonal antibodies, tislelizumab components, or capecitabine
- Previous tumor-specific surgery, radiotherapy, chemotherapy, targeted or immunotherapy
- Use of immunosuppressive drugs or systemic hormones (high dose) within 2 weeks before study
- Live attenuated vaccine within 4 weeks before study drug
- Major surgery or severe trauma within 4 weeks before study drug
- Active autoimmune diseases or history of immunodeficiency
- Poorly controlled cardiac conditions
- Severe infection within 4 weeks before study drug
- Active tuberculosis infection or history without formal treatment
- Active hepatitis B or C infection
- Other cancers within 5 years except low-risk treated skin cancers
- Pregnant or breastfeeding women
- Other serious illnesses or factors affecting safety or compliance as judged by investigator
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Approximately 13 weeks
Participants receive neoadjuvant chemoradiotherapy combined with immunotherapy or chemoradiotherapy alone. The experimental group receives radiotherapy with capecitabine and tislelizumab at weeks 2, 5, and 8, followed by two cycles of CAPOX chemotherapy. The control group receives radiotherapy with capecitabine and two cycles of CAPOX chemotherapy.
Weekly visits during radiotherapy and treatment cycles
Duration - Up to 10 weeks after radiotherapy
Participants undergo multiple examinations including colonoscopy and MRI about 8 to 10 weeks after completing radiotherapy to assess treatment response and plan subsequent care.
1 to 2 visits for examinations
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
H
Hongwei Yao
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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