Analysis of PD-L1, TMB, MSI and ctDNA Dynamics to Predict and Monitor Response to Immunotherapy in Metastatic Cancer.

NCT06227728 | Recruiting

• 1 other identifier: GS_ZIL
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

This is an observational clinical trial, aiming to investigate whether the ctDNA dynamics could predict early response to ICIs in patients with advanced-stage cancer. Moreover, conventional tumor markers PD-L1, TMB and MSI are to be investigated for their combined prognostic values in ICI treatment.

Conditions

Non Small Cell Lung Cancer; Breast Cancer; Colorectal Cancer; Gastric Cancer; Liver Cancer; Advanced Cancer; Immune Checkpoint Inhibitor

Outcome Measures

Primary Outcomes (4)

• To investigate the relationship between ctDNA dynamics and clinical response to immune checkpoint inhibitors (ICIs) (assessed by RECIST 1.1).

  * No response/progressive disease = ctDNA levels increase from baseline * Partial response/stable disease = ctDNA levels decrease from baseline * Complete response = ctDNA clearance.

  24 months

• To compare and combine ctDNA dynamics and RECIST1.1 to predict clinical response in case of pseudoprogression

  * Correlation between ctDNA dynamics and clinical response * Correlation between RECIST1.1 and clinical response * Combination of ctDNA dynamics and RECIST v1.1 in the prognosis of clinical response.

  24 months

• To investigate the prognostic value of ctDNA clearance with PFS and OS

  * Correlation between ctDNA clearance and PFS * Correlation between ctDNA clearance and OS.

  12-24 months

• To compare the prognostic values of PD-L1, TMB and MSI in predicting clinical response to ICI, best indicator(s) for ICI response.

  * Correlation between PD-L1 and clinical response * Correlation between TMB and clinical response * Correlation between MSI and clinical response.

  24 months

Eligibility Criteria

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

Study Population

This study population will include female and male, aged 18 and older, who are diagnosed with advanced stage of Non-small cell lung cancer, breast cancer, colorectal cancer, gastric caner and liver caner and indicated for ICI or ICI combined with chemotherapy. Eligible participants will meet all of the inclusion and exclusion criteria to be recruited into this study.

You may qualify if:

• years and older, both genders.
• Patients are diagnosed with stage IV cancer (lung, colorectal, breast, liver, gastric…) and indicated for ICI (first or second line). Concurrent chemotherapy with ICI is allowed.
• FFPE/FNA sample is available.
• Compliant with treatment protocol.
• Patients consented to participate in the study.

You may not qualify if:

• Patients already started ICI before enrollment.
• Consolidation ICI (eg. Durvalumab).
• Patients already started chemotherapy before enrollment.
• Medical or psychiatric conditions or occupational responsibilities that may preclude compliance with the protocol.
• Patients did not agree to participate in the studies.

Sponsors & Collaborators

• Gene Solutions: lead

Study Sites (2)

University of Medicine and Pharmacy at HCMC

Ho Chi Minh City, Hồ Chí Minh, Vietnam

RECRUITING

Medical Genetics Institute

Ho Chi Minh City, Vietnam

NOT YET RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

The 1st blood sample is collected from eligible participants who are diagnosed as advanced non-small cell lung cancer, breast cancer, colorectal cancer, gastric cancer and liver cancer before ICI therapy and/or chemotherapy. The 2nd - 5th blood sample are collected from the participants every 3 months during ICI therapy, 6-8 sections of formalin-fixed paraffin-embedded (FFPE) tumor samples before ICI and chemotherapy are also collected.

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Breast Neoplasms; Colorectal Neoplasms; Stomach Neoplasms; Liver Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Stomach Diseases; Liver Diseases

Study Officials

• Sinh D Nguyen

  MGI

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lan NL Tu, PHD

CONTACT

+84888843489; lantu@genesolutions.vn

VAN T Phan, MSc

CONTACT

+84908145990; vanphan@genesolutions.vn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2024
• First Posted: January 29, 2024
• Study Start: March 22, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 16, 2026

Record last verified: 2025-07

Locations

VN (2)