Clinical Trials Logo

Clinical Trial Summary

Backgrounds: A multicenter randomized phase III trial (NCT02605265) proved that adding irinotecan guided by UGT1A1 to capecitabine-based neoadjuvant chemoradiotherapy significantly increases complete tumor response. The treatment toxicities were increased but tolerable.

Purposes: This study aims to identify the predictive biomarkers (from patients' tumor biopsy samples and peripheral blood samples before neoadjuvant therapy) for predicting the response and toxicities to neoadjuvant therapy to stratify patients and optimize treatment strategy.


Clinical Trial Description

OBJECTIVES:

Primary:

- Establish a predictive model for response based on tissue RNA and plasma exosome RNA

- Establish a predictive model for toxicities based on tissue RNA and plasma exosome RNA

Secondary:

- Internal validation of the established predictive models

- External validation of the established predictive models

OUTLINE:

-Treatment: Patients receive neoadjuvant therapy and surgery per the protocol. Samples collection Tumor tissue and peripheral blood will be collected prior to neoadjuvant therapy.

-Grouping: Response: Patients will be dichotomized into two groups based on the TRG. TRG of 0-1 is defined as good response. TRG of 2-3 is defined as poor response.

Toxicities: Patients will be dichotomized into two groups based on the grade of AEs. No grade 3-4 toxicities occurs during neoadjuvant therapy is defined as light toxicities. Grade 3-4 toxicities occur during neoadjuvant therapy is defined as heavy toxicities.

-Predictive Model Construction: Using RNA sequencing method to obtain the whole genome transcription profiles of the tumor tissue and plasm exosome RNA. Compare the gene expression differences between the two response groups and the two toxicity groups. Predictive models of response and toxicities are constructed.

-Internal Validation: Patients treated at Fudan University Shanghai Cancer Center (N=50) per the protocol will be enrolled as the internal validation cohort. Samples of tissue and plasm will be collected and analyzed. The performance of the model will be evaluated by the correlation of the predicted response/toxicities and the actual response/toxicities.

-External Validation: Patients treated at Liao'ning Cancer Hospital & Institute (N=50) and Harbin Medical University Cancer Hospital (N=50) per the protocol will be enrolled as two external validation cohorts. Samples of tissue and plasm will be collected and analyzed. The performance of the model will be evaluated by the correlation of the predicted response/toxicities and the actual response/toxicities. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04227886
Study type Observational
Source Fudan University
Contact Ji Zhu, MD
Phone +86-2164175590
Email leo.zhu@126.com
Status Recruiting
Phase
Start date December 1, 2019
Completion date December 31, 2021

See also
  Status Clinical Trial Phase
Recruiting NCT05678218 - Preoperative Evaluation of Lymph Nodes of Cholangiocarcinoma
Recruiting NCT05161572 - Perioperative Chemoimmunotherapy With/Without Preoperative Chemoradiation for Locally Advanced Gastric Cancer Phase 2
Recruiting NCT02292641 - Beyond TME Origins N/A
Withdrawn NCT05325164 - Methadone for 'Adenocarcinopathic' Pain Treatment Phase 3
Completed NCT02926768 - Phase I/II Study of CK-101 in NSCLC Patients and Other Advanced Solid Tumors Phase 1
Recruiting NCT02125240 - Icotinib Versus Placebo as Adjuvant Therapy in EGFR-mutant Lung Adenocarcinoma Phase 3
Completed NCT02374411 - Knowledge, Attitudes, and Practice of Surgeons Toward Nutrition Support in HIPEC Patients N/A
Completed NCT02454647 - Induction Chemotherapy, Chemoradiotherapy and Surgery in Locally Advanced Gastric Cancer Patients N/A
Completed NCT01579721 - Prospective Randomized Study of SILS Versus CLS for Rectal Cancer Phase 4
Withdrawn NCT01148082 - School Response to Families Who Have Children With Cancer N/A
Completed NCT01206530 - FOLFOX/Bevacizumab/Hydroxychloroquine (HCQ) in Colorectal Cancer Phase 1/Phase 2
Completed NCT00548548 - A Study of Bevacizumab in Combination With Capecitabine and Cisplatin as First-line Therapy in Patients With Advanced Gastric Cancer Phase 3
Completed NCT00129844 - Study of Motexafin Gadolinium (MGd) for Second Line Treatment of Non-Small-Cell Lung Cancer Phase 2
Completed NCT00377936 - EndoTAG-1 / Gemcitabine Combination Therapy to Treat Locally Advanced and/or Metastatic Adenocarcinoma of the Pancreas Phase 2
Completed NCT00183859 - Clinical and Pharmacokinetic Trial of Intra-Abdominal Irinotecan Phase 1
Recruiting NCT01930864 - Metformin Plus Irinotecan for Refractory Colorectal Cancer Phase 2
Completed NCT02498860 - Efficacy and Safety of Adjuvant Pemetrexed Plus Cisplatin for Adenocarcinoma of Lung Phase 2
Terminated NCT01441128 - -02341066 and PF-00299804 for Advanced Non-Small Cell Lung Cancer Phase 1
Active, not recruiting NCT04400474 - Trial of Cabozantinib Plus Atezolizumab in Advanced and Progressive Neoplasms of the Endocrine System. The CABATEN Study Phase 2
Recruiting NCT02133196 - T Cell Receptor Immunotherapy for Patients With Metastatic Non-Small Cell Lung Cancer Phase 2