NCT06312982

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
375

participants targeted

Target at P75+ for phase_2

Timeline
8mo left

Started Mar 2024

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress77%
Mar 2024Dec 2026

First Submitted

Initial submission to the registry

March 9, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 15, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

March 16, 2024

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

January 13, 2026

Status Verified

July 1, 2025

Enrollment Period

2.7 years

First QC Date

March 9, 2024

Last Update Submit

January 12, 2026

Conditions

Locally Advanced Rectal Carcinoma

Outcome Measures

Primary Outcomes (1)

  • CR

    complete response rate=(number of pathological complete responses + number of clinical complete responses)/total number of patients

    pCR :within 10 days after surgery;cCR :13 weeks after radiotherapy begins

Secondary Outcomes (5)

  • AE rate

    during treatment

  • NAR score

    within 10 days after surgery

  • ORR

    within 10 days after surgery

  • OPR

    immediately after surgery

  • immune-related adverse event rate

    up to 3 weeks after using tislelizumab

Study Arms (2)

Experimental group

EXPERIMENTAL

The enrolled patients 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. Eight to 8-10 weeks after the completion of radiation therapy, patients will undergo multiple examinations, including colonoscopy and MRI. Subsequent treatment options will be determined by each center physician based on their clinical experience.

Drug: Tislelizumab

Control group

NO INTERVENTION

This group required only 5 weeks of NCRT and 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.

Interventions

TislelizumabDRUG

Enrolled patients will receive tislelizumab 3 times after initiation of radiotherapy.

Experimental group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed a written informed consent form and volunteered to join the study;
  • Age: 18-75 years old, male or female;
  • Pathohistologically confirmed rectal adenocarcinoma, along with immunohistochemical results of pMMR or genetic test results of MSS;
  • The baseline clinical stage assessed by MRI was T1-2N1-2M0 or T3N0-2M0, MRF (-), lateral lymph nodes (-);
  • The lower tumor margin is 10cm away from the anal margin;
  • Surgical resection;
  • Ability to swallow tablets normally;
  • ECOG PS 0-1；
  • Have not received any anti-tumor treatment for rectal cancer, including radiotherapy, chemotherapy, surgery, etc.;
  • Plan to undergo surgery after the completion of the neoadjuvant therapy;
  • No contraindications to surgery;
  • Main organ function is normal.

You may not qualify if:

  • Previous history of allergy to monoclonal antibodies, any component of tislelizumab,and capecitabine;
  • Previously has received or is receiving any of the following treatments:
  • A)Any tumor-specific surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc; B)Treatment with immunosuppressive drugs or systemic hormones within 2 weeks of first use (dose\> 10mg / day prednisone or equivalent dose); inhaled or topical steroids and dose\> 10mg / day prednisone or equivalent dose of adrenocorticoid replacement in the absence of active autoimmune disease; C)Having received a live attenuated vaccine within 4 weeks before the first use of the study drug; D)Major surgery or severe trauma within 4 weeks before the first use of study drug;
  • History of any active autoimmune or autoimmune disease, including but not limited to: interstitial pneumonia, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (considered after hormone replacement therapy); patients with psoriasis or asthma / allergy in childhood and adults without any intervention, but patients requiring medical intervention with bronchodilators should not be included;
  • A history of immunodeficiency, including a positive HIV test, or other acquired or congenital immunodeficiency disease, or a history of organ transplantation or allogeneic bone marrow transplantation;
  • Not well controlled cardiac clinical symptoms or disease, including but not limited to: such as (1) grade NYHA II above heart failure, (2) unstable angina, (3) myocardial infarction within 1 year, (4) clinical meaningful supraventricular or ventricular arrhythmia without clinical intervention or clinical intervention still poor control;
  • Severe infection (Grade CTCAE\> 2) within 4 weeks prior to the first use of study drug, Such as severe pneumonia, bacteremia, infection complications requiring hospitalization; Baseline chest imaging indicated the presence of active lung inflammation, presence of symptoms and signs and signs of infection within 14 days prior to the first administration of study drug or need for oral or intravenous antibiotics, Except for the preventive use of antibiotics; Found active tuberculosis infection by history or CT, Or those with a history of active tuberculosis infection within 1 year prior to enrollment, Or those with a history of active tuberculosis infection more than 1 year ago but without formal treatment;
  • Presence of active hepatitis B (HBV DNA 2000 IU / mL or 104copies / mL), hepatitis C (positive for hepatitis C antibody, and HCV RNA above the lower limit of detection of the analytical method);
  • A diagnosis of other malignancies within 5 years prior to the first use of study drug, unless a malignancy with low risk of metastasis or death (5-year survival\> 90%), such as adequately treated skin basal cell carcinoma or squamous cell carcinoma in situ, are considered;
  • Women in pregnancy or lactation;
  • Other factors, as judged by the investigator, may lead to forced termination of the study, such as other serious illness (including mental illness), alcohol, substance abuse, family or social factors, which may affect the safety or compliance of the subject.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

RECRUITING

Beijing Friendship Hospital

Beijing, Beijing Municipality, 100050, China

RECRUITING

MeSH Terms

Interventions

tislelizumab

Central Study Contacts

Zhongtao Zhang, MD

CONTACT

+86 13801060364Zhangzht@ccmu.edu.cn

Hongwei Yao

CONTACT

+8613611015609yaohongwei@ccmu.edu.cn

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
The professor

Study Record Dates

First Submitted

March 9, 2024

First Posted

March 15, 2024

Study Start

March 16, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

January 13, 2026

Record last verified: 2025-07

Locations

CN(2)