RecruitingPhase 2NCT06647680

Neoadjuvant Chemotherapy and PD-1 Inhibitor for Locally Advanced Rectal Cancer（CONTROL-01）

Neoadjuvant Chemotherapy and Tislelizumab (PD-1 Inhibitior) for Locally Advanced Rectal Cancer: a Single-center, Prospective, Phase II Study

Sponsor

The Affiliated Hospital of Qingdao University

Enrollment

35 participants

Start Date

Jun 1, 2025

Study Type

INTERVENTIONAL

Conditions

Rectal Cancer Patients

Summary

To evaluate the safety and preliminary efficacy of preoperative chemotherapy and PD-1 inhibitor Tislelizumab for Rectal Cancer patients.Go through laboratory and medical tests to verify eligibility to enter the study, receive the experimental combination of drugs CAPOX (Oxaliplatin and Capecitabine) for 3 cycles prior to surgery and undergo laboratory tests and study procedures on specified days during the study period, complete end of study evaluations and tests, and participate in post-study follow up every three months for three years.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study (CONTROL-01) is testing whether combining standard chemotherapy with a PD-1 immunotherapy drug as pre-surgery (neoadjuvant) treatment improves outcomes in patients with locally advanced rectal cancer that has not yet spread to distant organs. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with rectal adenocarcinoma confirmed by pathology - Your cancer is classified as stage T3 or T4 (has grown through the rectal wall) with no distant spread - You are in good general health and able to carry out most normal activities - Your blood counts, liver, and kidney function meet required levels - You have no other active cancers **You may NOT be eligible if...** - You are younger than 18 years old - You are pregnant or breastfeeding - You have had a prior invasive cancer in the past few years - You have significant abnormalities in blood counts, liver, or kidney function - You are unable to comply with the study requirements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGReceive the experimental combination of drugs (chemoradiation (Oxaliplatin and Capecitabine) + PD-1 inhibitor (Tislelizumab) for 3 cycles

Receive the experimental combination of drugs (chemoradiation (Oxaliplatin and Capecitabine) + PD-1 inhibitor (Tislelizumab) for 3 cycles prior to surgery and undergo laboratory tests and study procedures on specified days during the study period, complete end of study evaluations and tests, and participate in post-study follow up every three months for three to four years. The time in the study will take approximately four - six hours during pre-study, study and end of study visits.