Modified SCRT Followed by Tislelizumab Plus CAPOX for Locally Advanced Rectal Cancer

August 14, 2025 updated by: Fujian Cancer Hospital

A Phase II Multicenter Clinical Trial of Modified Short-course Radiotherapy Combined With CAPOX and PD-1 Monoclonal Antibody for Locally Advanced Mid-low Rectal Cancer

To explore the complete response (CR) rate of modified short-course radiotherapy combined with CAPOX and tislelizumab for locally Advanced Mid-low Rectal Cancer

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In the neoadjuvant treatment of rectal cancer, the new mode of short-course radiotherapy and chemotherapy combined with immunotherapy has shown good potential for application. Combining PD-1 antibody with short-course radiotherapy and chemotherapy to increase the tumour-killing and immune-mediated effects of the radiation dose may further improve tumour regression and increase the complete remission rate, providing a promising treatment option for patients with low-grade rectal cancer who are seeking a 'wait-and-see' strategy to preserve organ function.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
38

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Chunkang Yang, Doctor
  • Phone Number: +86 13509333116
  • Email: chuck330@163.com

Study Contact Backup

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350014
        • Fujian Cancer Hospital
      • Longyan, Fujian, China, 364000
        • The Second Hospital of Longyan
      • Quanzhou, Fujian, China, 362200
        • Jinjiang Municipal Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 18-75 years, any gender.
  • Pathologically confirmed rectal adenocarcinoma.
  • Baseline MR stage T3-4/N+.
  • Distance from anal verge ≤12cm.
  • No distant metastasis.
  • Karnofsky Performance Status ≥70.
  • Adequate organ function, no contraindications to surgery, radiotherapy, or immunotherapy.
  • Microsatellite/mismatch repair status MSS/pMMR.
  • No prior chemotherapy or any other anti-tumor treatment before inclusion.
  • No prior immunotherapy.
  • Ability to comply with the study protocol during the study period.
  • Signed written informed consent.

Exclusion Criteria:

  • Pregnant or lactating women.
  • Pathological diagnosis of signet ring cell carcinoma.
  • History of other malignancies within the past 5 years, except cured skin cancer and cervical carcinoma in situ.
  • Uncontrolled epilepsy, central nervous system disorders, or history of psychiatric disorders that, in the opinion of the investigator, may interfere with signing the informed consent form or affect patient compliance with oral medication.
  • Clinically significant (i.e., active) cardiac disease, such as symptomatic coronary artery disease, New York Heart Association (NYHA) Class II or greater congestive heart failure, or significant arrhythmias requiring drug intervention (see Appendix 12), or history of myocardial infarction within the past 12 months.
  • Organ transplant recipients requiring immunosuppressive therapy and long-term steroid users.
  • Patients with autoimmune diseases.
  • Severe uncontrolled recurrent infections or other severe uncontrolled comorbidities.
  • Subjects with baseline hematological and biochemical parameters not meeting the following criteria: hemoglobin ≥90g/L; absolute neutrophil count (ANC) .≥1.5×10^9/L; platelets ≥100×10^9/L; ALT, AST ≤2.5 times the upper limit of normal; ALP ≤2.5 times the upper limit of normal; serum total bilirubin <1.5 times the upper limit of normal; serum creatinine <1 times the upper limit of normal; serum albumin ≥30g/L.
  • Known deficiency of dihydropyrimidine dehydrogenase (DPD).
  • Allergy to any investigational drug components.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Modified Short-course Radiotherapy Combined with CAPOX and Tislelizumab
Modified SCRT (GTV 30Gy/5f, CTV 22.5Gy/5f), followed by Tislelizumab and CAPOX q3w *2 cycles. Efficacy and surgery were assessed 2-4 weeks after the end of treatment.
Drug: Tislelizumab
Tislelizumab：200mg，d1，q3w，2 cycles.
Radiation: Short-course Radiotherapy
Rectal lesion + metastatic lymph nodes, GTV 30Gy/5Fx. Pelvic lymphatic drainage area, CTV 22.5Gy/5Fx.
Drug: Capecitabine
Capecitabine：1000mg/m2，d1-14，bid, q3w, 2 cycles.
Drug: Oxaliplatin
Oxaliplatin：130mg/m2, d1, q3w, 2 cycles

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Complete response (CR) rate
Time Frame: From enrollment to 3 month and during follow-up
Including pCR and CCR.
From enrollment to 3 month and during follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
3y-DFS
Time Frame: From enrollment to 36 month
From enrollment to 36 month
Organ preservation rate
Time Frame: 1 year.
Sphincter-saving rate in enrolled patients
1 year.
3-year OS
Time Frame: From enrollment to 36 month
The percentage of patients enrolled who are still alive three years after their initial enrollment.
From enrollment to 36 month
Quality of life
Time Frame: Before each treatment, before surgery and during follow-up.
EORTC Core Quality of Life questionnaire (QLQ-C30)，range from 0-100, with comprehensive assessment indicators, including positive and negative indicators.
Before each treatment, before surgery and during follow-up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fujian Cancer Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 12, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 10, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 14, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 20, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 27, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 15, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CATIMOR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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