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The Clinical Efficacy of Drug Sensitive Neoadjuvant Chemotherapy Based on Organoid Versus Traditional Neoadjuvant Chemotherapy in Advanced Rectal Cancer

NCT05352165 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 192

Last updated 2022-04-28

No results posted yet for this study

Summary

This is a prospective multicenter randomized controlled trial study. According to the enrollment criteria, patients with locally advanced rectal cancer who need neoadjuvant therapy before radical surgery were randomly divided into the organoids drug sensitivity group and the standard whole-course neoadjuvant therapy group. The Organoids drug sensitivity group was treated with personalized neoadjuvant therapy under the guidance of tumor organoids drug sensitivity technology combined with standard long-term radiotherapy. The standard whole-course neoadjuvant therapy group was treated with neoadjuvant simultaneous radiotherapy and chemotherapy (Total Neoadjuvant Therapy, TNT) based on guidelines and clinical experience. The tumor pathological complete remission rate (pCR), postoperative complication rate, postoperative tumor withdrawal grade, postoperative recurrence rate, treatment tolerance rate, R0 resection rate, and sphincter preservation rate were observed and compared.

Conditions

  • Neoadjuvant Therapy

Interventions

DRUG

standard long-term therapy

The standard whole-course neoadjuvant therapy group was treated with neoadjuvant simultaneous radiotherapy and chemotherapy (Total Neoadjuvant Therapy, TNT) based on guidelines and clinical experience.

DRUG

FOLFOX and standard long-term radiotherapy

FOLFOX and standard long-term radiotherapy based on organoids drug sensitivity

DRUG

FOLFIRI and standard long-term radiotherapy

FOLFIRI and standard long-term radiotherapy based on organoids drug sensitivity

DRUG

5-FU and standard long-term radiotherapy

5-FU and standard long-term radiotherapy based on organoids drug sensitivity

DRUG

5-FU and pembrolizumab and standard long-term radiotherapy

5-FU and pembrolizumab and standard long-term radiotherapy based on organoids drug sensitivity

DRUG

Other individualized treatments

Other individualized treatments based on organoids drug sensitivity

Sponsors & Collaborators

  • Shanghai OneTar Biomedicine Co., Ltd.

    collaborator UNKNOWN

  • Ruijin Hospital

    collaborator OTHER

  • Shanghai Minimally Invasive Surgery Center

    lead OTHER

Principal Investigators

  • Jing Sun, PhD · Shanghai Minimally Invasive Surgery Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-01
Primary Completion
2024-12-31
Completion
2025-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05352165 on ClinicalTrials.gov