Clinical trial · Interventional

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

A Prospective Multicenter Randomized Controlled Trial of the Clinical Efficacy of Neoadjuvant Therapy Based on Organoids Drug Sensitivity Versus Empirical Neoadjuvant Therapy in the Treatment of Advanced Rectal Cancer

NCT05352165CI-TRIAL-00058130unknownN/AClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Neoadjuvant Therapy	—	UNRESOLVED	—

Interventions

Interventions (6)

Intervention	Type	Mapped drug	Match
5-FU and pembrolizumab and standard long-term radiotherapy	Drug	—	UNRESOLVED
5-FU and standard long-term radiotherapy	Drug	—	UNRESOLVED
FOLFIRI and standard long-term radiotherapy	Drug	—	UNRESOLVED
FOLFOX and standard long-term radiotherapy	Drug	—	UNRESOLVED
Other individualized treatments	Drug	—	UNRESOLVED
standard long-term therapy	Drug	—	UNRESOLVED

Design

Arms and outcomes

Arms (6)

type
EXPERIMENTAL
label
standard long-term therapy
description
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.
interventionNames
1. Drug: standard long-term therapy
2. Drug: FOLFOX and standard long-term radiotherapy
3. Drug: FOLFIRI and standard long-term radiotherapy
4. Drug: 5-FU and standard long-term radiotherapy
5. Drug: 5-FU and pembrolizumab and standard long-term radiotherapy
6. Drug: Other individualized treatments
type
ACTIVE_COMPARATOR
label
FOLFOX and standard long-term radiotherapy
description
FOLFOX and standard long-term radiotherapy based on organoids drug sensitivity
interventionNames
1. Drug: standard long-term therapy

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 75 Years

Show eligibility criteria text

Inclusion Criteria:

* 1\) Age: 18-75. 2) qualitative diagnosis: adenocarcinoma was confirmed by enteroscopic biopsy. 3) Localization diagnosis: the tumor is located in the rectum (the distance between the tumor and the anal margin ≤ 12cm).

  4\) plain scan of thoracoabdominal pelvis and enhanced CT or MRI evaluation of rectal cancer staging:

The primary tumor invades the muscular layer of the intestinal wall into the surrounding well-known structure, with or without lymph node metastasis in the proper rectal fascia.

b. TNM clinical or pathological stage of tumor: T3-T4N0-2M0. 5) physical condition (ECOG) score ≤ 1. 6) all patients agreed to receive adjuvant chemotherapy for 3 to 6 months after operation.

7\) sign informed consent and participate in the project voluntarily.

Exclusion Criteria:

* 1\) simultaneous or metachronous multiple primary malignant tumors. 2) preoperative imaging examination or pathological results showed that:

Lateral lymph node metastasis. b. Distant organ metastasis. 3) previous history of malignant tumors. 4) abnormal function of heart, lung, liver, kidney, hematopoiesis and bone marrow reserve, which can not tolerate neoadjuvant therapy and operation.

5\) have mental illness or other serious cardiovascular disease. 6) pregnant or lactating women. 7) Emergency surgery (perforation, bleeding, intestinal obstruction, etc.). 8) BRAF mutation was found by gene detection.

References

Publications (7)

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BACKGROUNDGarcia-Aguilar J, Chow OS, Smith DD, Marcet JE, Cataldo PA, Varma MG, Kumar AS, Oommen S, Coutsoftides T, Hunt SR, Stamos MJ, Ternent CA, Herzig DO, Fichera A, Polite BN, Dietz DW, Patil S, Avila K; Timing of Rectal Cancer Response to Chemoradiation Consortium. Effect of adding mFOLFOX6 after neoadjuvant chemoradiation in locally advanced rectal cancer: a multicentre, phase 2 trial. Lancet Oncol. 2015 Aug;16(8):957-66. doi: 10.1016/S1470-2045(15)00004-2. Epub 2015 Jul 14. PMID 26187751
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BACKGROUNDSato T, Vries RG, Snippert HJ, van de Wetering M, Barker N, Stange DE, van Es JH, Abo A, Kujala P, Peters PJ, Clevers H. Single Lgr5 stem cells build crypt-villus structures in vitro without a mesenchymal niche. Nature. 2009 May 14;459(7244):262-5. doi: 10.1038/nature07935. Epub 2009 Mar 29.