Low Rectal Cancer Treated With Total Neoadjuvant Therapy Plus Concurrent Tislelizumab Immunotherapy

NCT07561060 | Recruiting Phase 1

• 1 other identifier: TNTIT
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Rectal Cancer

Outcome Measures

Primary Outcomes (1)

• Complete Response rate (CR rate)

  defined as the proportion of participants with clinical complete response(cCR) or near clinical complete response (ncCR) who achieved local resection confirmed pCR determined by the investigators after 4-6 cycles total neoadjuvant therapy plus concurrent tislelizumab immunotherapy.

  From first dose up to 12 months, approximately

Secondary Outcomes (4)

• 1/2/3 year organ-preservation rate

  From first dose of radiotherapy up to 36 months, approximately

• 1/2/3 year EFS rate

  From first dose of radiotherapy up to 36 months, approximately

• 1/2/3 year OS rate

  From first dose of radiotherapy up to 36 months, approximately

• Percentage of Participants With Adverse Events

  From first dose of radiotherapy up to 36 months, approximately

Study Arms (1)

tislelizumab

EXPERIMENTAL

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).

Drug: Tislelizumab; Drug: Capecitabine; Drug: Oxaliplatin

Interventions

Tislelizumab DRUG

200 mg IV on Day 1 of each 21-day cycle.

tislelizumab

Capecitabine DRUG

Capecitabine 1000 mg/m2 orally twice daily (bid) on Day 1 to 14 of each 21-day cycle in CAPOX regimen

tislelizumab

Oxaliplatin DRUG

130 mg/m2 IV on Day 1 of each 21-day cycle in CAPOX regimen

tislelizumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to provide written informed consent, understand and comply with the requirements and evaluation schedule
• ≥18, ≤75 years old
• Histologically confirmed rectal adenocarcinoma
• immunohistochemistry confirmed pMMR (positive for MLH1, MSH2, MSH6 and PMS2), or PCR /NGS confirmed MSI-L or MSS
• The tumor is within 3 cm of the dentate line. through colonoscopy, digital anal examination or MRI
• clinical stage cT1-3 N 0-1M0 (the 8th UICC/AJCC; T and N is evaluated by MRI)
• Resectable primary tumor assessed by the Investigator
• Have not received any anti-tumor treatment for rectal cancer
• ECOG PS ≤ 1
• Adequate organ function
• Female subjects with the ability to become pregnant must have a serum pregnancy test with a negative result within 72 hours before the first dose, and be willing to use highly effective contraceptive methods during the trial and 120 days after the last dose. Male subjects whose partners are women of childbearing potential should be surgically sterilized or agree to use a highly effective method of contraception during the trial and for 120 days after the last dose.

You may not qualify if:

• Histologically confirmed poorly differentiated/undifferentiated adenocarcinoma, mucinous adenocarcinoma and signet ring cell carcinoma
• Have received any treatments for rectal cancer, or evidence of distant metastasis
• Presence of following high risk factors assessed by MRI: MRF +, EMVI+, cN2, Positive lateral lymph nodes, T3d
• Presence or in high risk of obstruction, perforation or bleeding;
• Not suitable for long-course radiotherapy
• Cannot tolerate surgery
• ≥2 colorectal cancer lesions at the same time
• Contraindications for MRI examination
• Other malignant tumors in the past or at the same time
• Have an active autoimmune disease requiring systemic therapy within the past 2 years
• HIV infection
• Untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers (HBV DNA \> 500 IU/mL) or active HCV carriers with detectable HCV RNA;
• Hypersensitivity to any ingredient of tislelizumab, capecitabine, and oxaliplatin or to any component of the container
• Other conditions judged by the researcher that do not meet the enrollment requirements

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Shanghai Zhongshan Hospital, Shanghai

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

tislelizumab; Capecitabine; Oxaliplatin

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes; Organic Chemicals

Central Study Contacts

Jianmin Xu, MD

CONTACT

+862164041990; xujmin@aliyun.com

Wenju Chang, MD

CONTACT

13764476150; chang_erich@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Shanghai Zhongshan Hospital

Study Record Dates

• First Submitted: April 26, 2026
• First Posted: May 1, 2026
• Study Start: January 1, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: May 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)