The Molecular Mechanism of RAS Wild-type mCRC Resistance to Anti-EGFR-antibody

NCT04466267 | Completed

• 1 other identifier: anti-EGFR-antibody
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Establishing the genetic map of primary and secondary resistance of Chinese wild RAS colorectal cancer received anti-EGFR treatment through tissues and peripheral blood NGS testing. Combination genetic data with clinical characteristics, prognosis and treatment data to explore the molecular mechanism of resistance of anti-EGFR-antibody.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• The molecular mechanism of patients primary or secondary resistance to cetuximab

  Dynamic monitoring ctDNA to identify potential molecular mechanism of RAS wild-type mCRC patients primary or secondary resistance to cetuximab

  up to 36 months

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

RAS wild-type metastatic colorectal cancer patients treatment with FOLFOX/FORFIRI + cetuximab

You may qualify if:

• Age≥18 years, ≤75 years, all gender;
• Histologically proven metastatic adenocarcinoma of colorectal cancer, no previous history of cancer;
• The clinical data of patient is intact;
• The data of patients after surgery is intact, and the prognosis follow-up data of patient is available.

You may not qualify if:

• Previous history of cancer；
• Intact clinical data or diagnosis results of histopathology is unavailable;
• Time of progression disease after treatment and follow-up data are unavailable;
• Patient received blood transfusion within 3 months;
• Other situation that researchers think it will impact the results of trails or violate ethics.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Medical Oncology,Sun Yat-sen University Cancer Center

Guanzhou, Guangdong, 510060, China

Location

Related Publications (5)

• Venook AP, Niedzwiecki D, Lenz HJ, Innocenti F, Fruth B, Meyerhardt JA, Schrag D, Greene C, O'Neil BH, Atkins JN, Berry S, Polite BN, O'Reilly EM, Goldberg RM, Hochster HS, Schilsky RL, Bertagnolli MM, El-Khoueiry AB, Watson P, Benson AB 3rd, Mulkerin DL, Mayer RJ, Blanke C. Effect of First-Line Chemotherapy Combined With Cetuximab or Bevacizumab on Overall Survival in Patients With KRAS Wild-Type Advanced or Metastatic Colorectal Cancer: A Randomized Clinical Trial. JAMA. 2017 Jun 20;317(23):2392-2401. doi: 10.1001/jama.2017.7105.

  PMID: 28632865 BACKGROUND

• Stintzing S, Modest DP, Rossius L, Lerch MM, von Weikersthal LF, Decker T, Kiani A, Vehling-Kaiser U, Al-Batran SE, Heintges T, Lerchenmuller C, Kahl C, Seipelt G, Kullmann F, Stauch M, Scheithauer W, Held S, Giessen-Jung C, Moehler M, Jagenburg A, Kirchner T, Jung A, Heinemann V; FIRE-3 investigators. FOLFIRI plus cetuximab versus FOLFIRI plus bevacizumab for metastatic colorectal cancer (FIRE-3): a post-hoc analysis of tumour dynamics in the final RAS wild-type subgroup of this randomised open-label phase 3 trial. Lancet Oncol. 2016 Oct;17(10):1426-1434. doi: 10.1016/S1470-2045(16)30269-8. Epub 2016 Aug 27.

  PMID: 27575024 BACKGROUND

• Tejpar S, Stintzing S, Ciardiello F, Tabernero J, Van Cutsem E, Beier F, Esser R, Lenz HJ, Heinemann V. Prognostic and Predictive Relevance of Primary Tumor Location in Patients With RAS Wild-Type Metastatic Colorectal Cancer: Retrospective Analyses of the CRYSTAL and FIRE-3 Trials. JAMA Oncol. 2017 Feb 1;3(2):194-201. doi: 10.1001/jamaoncol.2016.3797.

  PMID: 27722750 BACKGROUND

• Batth IS, Mitra A, Manier S, Ghobrial IM, Menter D, Kopetz S, Li S. Circulating tumor markers: harmonizing the yin and yang of CTCs and ctDNA for precision medicine. Ann Oncol. 2017 Mar 1;28(3):468-477. doi: 10.1093/annonc/mdw619.

  PMID: 27998963 BACKGROUND

• Vidal J, Muinelo L, Dalmases A, Jones F, Edelstein D, Iglesias M, Orrillo M, Abalo A, Rodriguez C, Brozos E, Vidal Y, Candamio S, Vazquez F, Ruiz J, Guix M, Visa L, Sikri V, Albanell J, Bellosillo B, Lopez R, Montagut C. Plasma ctDNA RAS mutation analysis for the diagnosis and treatment monitoring of metastatic colorectal cancer patients. Ann Oncol. 2017 Jun 1;28(6):1325-1332. doi: 10.1093/annonc/mdx125.

  PMID: 28419195 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Tissues and peripheral blood

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Ying Jin, MD.,PhD

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: July 6, 2020
• First Posted: July 10, 2020
• Study Start: March 1, 2017
• Primary Completion: March 1, 2020
• Study Completion: July 4, 2020
• Last Updated: July 10, 2020

Record last verified: 2020-07

Locations

CN (1)