NCT04227886

Study on Predictive Biomarkers of Neoadjuvant Chemoradiotherapy for Rectal Cancer

Status unknown Last updated 14 January 2020

What this trial tests

trial testing Radiation in Rectal Neoplasm Malignant Carcinoma in 250 participants. Status unknown.

Timeline

1 December 2019

Primary endpoint
31 December 2020

31 December 2021

Quick facts

Lead sponsor	Fudan University
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	250
Start date	1 December 2019
Primary completion	31 December 2020
Estimated completion	31 December 2021
Sites	1 location across China

Drugs / interventions tested

• Radiation
• Capecitabine-Irinotecan Combination

Conditions studied

• Rectal Neoplasm Malignant Carcinoma — all drugs for Rectal Neoplasm Malignant Carcinoma →
• Chemoradiotherapy — all drugs for Chemoradiotherapy →
• Neoadjuvant Therapy — all drugs for Neoadjuvant Therapy →
• Predictive Biomarkers — all drugs for Predictive Biomarkers →

Sponsor

Fudan University

Who can join

Adults 18 to 75, any sex, with Rectal Neoplasm Malignant Carcinoma or Chemoradiotherapy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Potential Use of Exosomes as Diagnostic Biomarkers and in Targeted Drug Delivery: Progress in Clinical and Preclinical Applications.
   Huda MN, Nafiujjaman M, Deaguero IG, Okonkwo J, et al · · 2021 · cited 160× · PMID 33988964 · DOI 10.1021/acsbiomaterials.1c00217
2. Clinical applications for exosomes: Are we there yet?
   Perocheau D, Touramanidou L, Gurung S, Gissen P, et al · · 2021 · cited 101× · PMID 33751579 · DOI 10.1111/bph.15432
3. Recent advances in conventional and unconventional vesicular secretion pathways in the tumor microenvironment.
   Kuo IY, Hsieh CH, Kuo WT, Chang CP, et al · · 2022 · cited 33× · PMID 35927755 · DOI 10.1186/s12929-022-00837-8
4. Extracellular Vesicles in Colorectal Cancer: From Tumor Growth and Metastasis to Biomarkers and Nanomedications.
   Kotelevets L, Chastre E. · · 2023 · cited 27× · PMID 36831450 · DOI 10.3390/cancers15041107
5. Exosomes: Insights and therapeutic applications in cancer.
   Panigrahi AR, Srinivas L, Panda J. · · 2022 · cited 27× · PMID 35551002 · DOI 10.1016/j.tranon.2022.101439
6. The biological function of tumor-derived extracellular vesicles on metabolism.
   Fu X, Song J, Yan W, Downs BM, et al · · 2023 · cited 22× · PMID 37349803 · DOI 10.1186/s12964-023-01111-6
7. An insight into small extracellular vesicles: Their roles in colorectal cancer progression and potential clinical applications.
   He X, Zhong X, Hu Z, Zhao S, et al · · 2020 · cited 19× · PMID 33377655 · DOI 10.1002/ctm2.249
8. The Role of Small Extracellular Vesicles in the Progression of Colorectal Cancer and Its Clinical Applications.
   Chang LC, Chiu HM, Wu MS, Shen TL. · · 2022 · cited 17× · PMID 35163305 · DOI 10.3390/ijms23031379