Breast Cancer Clinical Trial
Official title:
Analysis of PD-L1, TMB, MSI and Circulating Tumor DNA Dynamics to Predict and Monitor Response to Immunotherapy in Metastatic Cancer.
NCT number | NCT06227728 |
Other study ID # | GS_ZIL |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | March 22, 2024 |
Est. completion date | December 31, 2026 |
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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | December 31, 2026 |
Est. primary completion date | December 1, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - 18 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Vietnam | Medical Genetics Institute | Ho Chi Minh City | |
Vietnam | University of Medicine and Pharmacy at HCMC | Ho Chi Minh City | H? Chí Minh |
Lead Sponsor | Collaborator |
---|---|
Gene Solutions |
Vietnam,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04681911 -
Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer
|
Phase 2 | |
Terminated |
NCT04066790 -
Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer
|
Phase 2 | |
Completed |
NCT04890327 -
Web-based Family History Tool
|
N/A | |
Completed |
NCT03591848 -
Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility
|
N/A | |
Recruiting |
NCT03954197 -
Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients
|
N/A | |
Terminated |
NCT02202746 -
A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer
|
Phase 2 | |
Active, not recruiting |
NCT01472094 -
The Hurria Older PatiEnts (HOPE) With Breast Cancer Study
|
||
Completed |
NCT06049446 -
Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
|
||
Withdrawn |
NCT06057636 -
Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study
|
N/A | |
Recruiting |
NCT05560334 -
A Single-Arm, Open, Exploratory Clinical Study of Pemigatinib in the Treatment of HER2-negative Advanced Breast Cancer Patients With FGFR Alterations
|
Phase 2 | |
Active, not recruiting |
NCT05501769 -
ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer
|
Phase 1 | |
Recruiting |
NCT04631835 -
Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer
|
Phase 1 | |
Completed |
NCT04307407 -
Exercise in Breast Cancer Survivors
|
N/A | |
Recruiting |
NCT03544762 -
Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation
|
Phase 3 | |
Terminated |
NCT02482389 -
Study of Preoperative Boost Radiotherapy
|
N/A | |
Enrolling by invitation |
NCT00068003 -
Harvesting Cells for Experimental Cancer Treatments
|
||
Completed |
NCT00226967 -
Stress, Diurnal Cortisol, and Breast Cancer Survival
|
||
Recruiting |
NCT06019325 -
Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy
|
N/A | |
Recruiting |
NCT06006390 -
CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A |