RecruitingPhase 1NCT06300489

Genotype-driven Weekly Irinotecan Liposomes in Combination With Capecitabine-based Neoadjuvant Chemoradiation for Locally Advanced Rectal Cancer

Genotype-driven Phase I Study of Weekly Irinotecan Liposomes in Combination With Capecitabine-based Neoadjuvant Chemoradiation for Locally Advanced Rectal Cancer


Sponsor

Zhejiang Cancer Hospital

Enrollment

30 participants

Start Date

Mar 3, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This study is a multicenter, open, and phase I dose increasing clinical study. Based on the UGT1A1 \* 28 and \* 6 genotypes of patients with locally advanced rectal cancer, determine the dose limiting toxicity (DLT) and maximum tolerable dose (MTD) of weekly irinotecan liposomes in concurrent chemoradiotherapy with capecitabine, investigate the tolerance of irinotecan liposome combined with capecitabine in concurrent chemoradiotherapy with locally advanced rectal cancer, and recommend the dosage for Phase II clinical study,and explore the pharmacokinetic characteristics of irinotecan liposomes combined with capecitabine.At the same time,Preliminary observe the efficacy and safety of irinotecan liposomes combined with capecitabine in chemoradiotherapy.The study plans to recruit 30 patients with advanced rectal cancer who have not received any therapy.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adjusting the dose of a chemotherapy drug called irinotecan (in a liposomal form) based on a patient's genetic makeup can improve treatment for locally advanced rectal cancer before surgery and radiation. Different patients process this drug differently based on their genes, so tailoring the dose could improve safety and effectiveness. **You may be eligible if...** - You are between 18 and 70 years old - You have been diagnosed with rectal adenocarcinoma by biopsy - Your cancer is locally advanced (stage T2–T4 and/or lymph node involvement) and not suitable for upfront surgery - Your tumor is within 10 cm of the anal opening - There is no sign of cancer spread to distant organs - You are in good health (ECOG score 0–1) - You have not received chemotherapy or other anti-cancer treatment before **You may NOT be eligible if...** - Your cancer has spread to other organs - You have already received chemotherapy or radiation for this cancer - You have serious heart, liver, or kidney problems 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

DRUGirinotecan liposomes+capecitabine

Radiotherapy:IMRT DT 50Gy/25Fx. Capecitabine: 625mg/m2 bid po d1-5 qw. For patients are double sites mutant (GG+7/7 or AA+6/6 or GA+6/7),the intial dose of Irinotecan liposomes is 25mg/m2 weekly,for four weeks。 This study stratify cases by the "3+3" rule according to UGT1A1 \* 6 and UGT1A1 \* 28 phenotypes. Three cases were enrolled in each dose group, and if there was no DLT, they were promoted to the next dose group(an increase of 5mg/m2); If there is 1 case of DLT, 3 cases will be reenrolled in the same dose group. If there is no new occurrence of DLT, it will be promoted to the next dose group. Otherwise, the study will be terminated; If there are 2 cases of DLT, the study will be terminated, and the previous dose group will be the maximum tolerated dose (MTD).


Locations(1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

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NCT06300489


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