Actively Recruiting
Low Rectal Cancer Treated With Total Neoadjuvant Therapy Plus Concurrent Tislelizumab Immunotherapy
Led by Fudan University · Updated on 2026-05-01
50
Participants Needed
1
Research Sites
217 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an open-label, multi-center, single-arm clinical study. All patients received 4-6 cycles total neoadjuvant therapy plus concurrent tislelizumab immunotherapy, then underwent clinical response assessment. Patients who achieved CR (cCR+ pCR confirmed by local resection of ncCR) continue tislelizumab combined with CAPOX for another 4 cycles and tislelizumab for 9 cycles, then Watch and Wait. Patients who did not achieved CR underwent total mesorectal excision (TME).
CONDITIONS
Official Title
Low Rectal Cancer Treated With Total Neoadjuvant Therapy Plus Concurrent Tislelizumab Immunotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to provide written informed consent and follow study procedures
- Aged 18 to 75 years
- Histologically confirmed rectal adenocarcinoma
- Confirmed pMMR by immunohistochemistry or MSI-L/MSS by PCR/NGS
- Tumor located within 3 cm of the dentate line by colonoscopy, digital anal exam, or MRI
- Clinical stage cT1-3 N0-1 M0 by MRI according to 8th UICC/AJCC
- Primary tumor assessed as resectable by Investigator
- No prior anti-tumor treatment for rectal cancer
- ECOG performance status 0 or 1
- Adequate organ function
- Female subjects able to become pregnant must have negative pregnancy test within 72 hours before first dose and agree to use effective contraception during and 120 days after treatment
- Male subjects with partners of childbearing potential must be surgically sterilized or agree to use effective contraception during and 120 days after treatment
You will not qualify if you...
- Poorly differentiated, undifferentiated adenocarcinoma, mucinous adenocarcinoma, or signet ring cell carcinoma
- Prior treatment for rectal cancer or evidence of distant metastasis
- High risk factors on MRI: MRF+, EMVI+, cN2, positive lateral lymph nodes, T3d
- High risk or presence of obstruction, perforation, or bleeding
- Unsuitable for long-course radiotherapy
- Unable to tolerate surgery
- Two or more colorectal cancer lesions simultaneously
- Contraindications for MRI
- Other malignant tumors currently or in the past
- Active autoimmune disease requiring systemic therapy within past 2 years
- HIV infection
- Untreated chronic hepatitis B or active hepatitis C infection
- Allergy to tislelizumab, capecitabine, oxaliplatin, or container components
- Other conditions judged unsuitable by researcher
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai Zhongshan Hospital, Shanghai
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
J
Jianmin Xu, MD
CONTACT
W
Wenju Chang, 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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