RecruitingPhase 3NCT06017583

Neoadjuvant Chemotherapy With PD-1 Inhibitors Combined With SIB-IMRT in the Treatment of Locally Advanced Rectal Cancer

Neoadjuvant Chemotherapy With PD-1 Inhibitors Combined With Simultaneous Integrated Boost Intensity-modulated Radiotherapy in the Treatment of Locally Advanced Rectal Cancer


Sponsor

Yong Zhang,MD

Enrollment

48 participants

Start Date

Sep 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This study aims to evaluate the efficacy and safety of tislelizumab combined with simultaneous integrated boost intensity-modulated radiotherapy in treating locally advanced rectal cancer. To explore a new PD-1 inhibitor adjuvant chemotherapy model combined with radiotherapy to treat locally advanced rectal cancer.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This trial tests whether combining an immunotherapy drug (a PD-1 inhibitor) with standard chemotherapy before surgery, along with a specialized radiation technique (SIB-IMRT), improves outcomes for people with locally advanced rectal cancer. **You may be eligible if...** - You are between 18 and 70 years old - You have confirmed rectal adenocarcinoma (a specific type of rectal cancer) that is locally advanced (T3–T4 or lymph node-positive) - You have not started any treatment yet - You are doing well enough in daily activities (ECOG 0–1) - Your blood counts and organ function meet required levels **You may NOT be eligible if...** - You have had other cancers in the last 5 years - You have received prior PD-1 or checkpoint immunotherapy - You have an active autoimmune disease or active infection - You are pregnant or breastfeeding - You have a history of heart attack, stroke, or severe heart failure 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

DRUGTislelizumab

Tirellizumab was administered intravenously at 200mg/d1, 21 days per cycle, with at least 4 cycles completed.

DRUGCapecitabine

Oral capecitabine 825mg/m2 bid, radiotherapy day concurrent chemotherapy. Chemotherapy regimen after radiotherapy: XELOX regimen: oxaliplatin intravenous infusion of 130mg/m2/d1+ oral capecitabine 1000mg/m2 bid/ d1-14, 21 days per cycle, at least 2 cycles completed.

DRUGOxaliplatin

Chemotherapy regimen after radiotherapy: XELOX regimen: oxaliplatin intravenous infusion of 130mg/m2/d1+ oral capecitabine 1000mg/m2 bid/ d1-14, 21 days per cycle, at least 2 cycles completed.

RADIATIONSIB-IMRT

The tumor and the related mesenteric region 1cm above and below were simultaneously integrated boost to 5600cGy with the intensity-modulated radiotherapy. The other dose for clinical target volume is 5000 cGy.

RADIATIONIMRT

The whole dose of the clinical target volume is 5000 cGy with intensity-modulated radiotherapy.


Locations(1)

First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

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