Therapeutic ResistAnce and Clonal Evolution Assessed With... | NCT05292443

Status Module

Record Verification Date

Feb 2024

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

No participants were enrolled

Expanded Access Info

Start Date

Dec 20, 2021Actual

Primary Completion Date

Mar 17, 2023Actual

Completion Date

Mar 17, 2023Actual

First Submitted Date

Mar 14, 2022

First Submission Date that Met QC Criteria

Mar 14, 2022

First Posted Date

Mar 23, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 21, 2024

Last Update Posted Date

Feb 23, 2024Actual

Name	Class
Eastern Hepatobiliary Surgery Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To evaluate the predictive value of ctDNA in response, relapse for liver cancer patients treated with immune checkpoint inhibitors

Detailed Description

In the study, 300 advanced primery liver cancer patients who received immune checkpoint inhibitors at first-line setting (N=200) or second-line setting (N=100) will be recruited. By analyzing the ctDNA and peripheral blood mononuclear cell (PBMC) collected before and after the first cycle of ICI treatment, the dynamic changes of bTMB, ctDNA and the composition of immune cells will be detected. Combined with the tumor markers AFP, DCP and CA19-9, a noninvasive multiparameter model will be developed.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

0Actual

Name	Type	Description	Arm Group Labels	Other Names
Observation	Other	observe the association of ctDNA with efficacy of treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
PFS: Progression-free survival	The time length from the date of randomization to any of the following events: disease progression or death from any cause.	24 months

Secondary Outcomes

Measure	Description	Time Frame
ORR: Objective Response Rate	The proportion of patients with complete response or partial response.	24 months
OS: Overall Survival	The time length from the date of randomization to the date of death.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Primary liver cancer diagnosed according to the clinical diagnostic criteria, or histopathological or cytological examination;
18-80 years old, no limit on gender;
ECOG performance status of 0-2, with expected survival time of more than 12 weeks;
According to RECIST V1.1, there must be at least one measurable lesion;
Patients who are suitable for ICIs treatment and willing to comply with required protocols and give permission to use the data for clinical research and products development;
Patients who join the study voluntarily, sign a consent form, have good compliance, and comply with follow-up.

Exclusion Criteria:

Patients with other primary cancers;
Patients with a severe parenchymal disease and unable to accept ICIs treatment;
Patients with a psychiatric disorder and unable to comply with this study;
Patients with symptomatic brain metastasis, anticipated complications or cognitive disorders that are associated with brain metastasis;
Adverse events related to prior anti-tumor treatment (except for hair loss of any grade) did not return to grade 1 or better;
History of cells or organ transplantation;
History of hypersensitivity to the drug administered in this study or contrast media for CT and MRI;
Patients who accepted hepatic local therapy (including ablation therapy, percutaneous injection of ethanol or acetic acid (PEI/PAI), high-intensity focused ultrasound (HIFU), transarterial chemoembolization (TACE)) within 14 days prior to initiation of the study;
Other reasons that the researchers think not suitable for ICIs treatment

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Primary liver cancer including hepatocellular carcinoma, intrahepatic cholangiocarcinoma and combined hepatocellular-cholangiocarcinoma

Sampling Method

Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Xuanwu Hospital Capital Medical University		Beijing	Beijing Municipality	100053	China
Beijing hospital

ID	Term
D006528	Carcinoma, Hepatocellular
D018281	Cholangiocarcinoma

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008113	Liver Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D004066	Digestive System Diseases
D008107	Liver Diseases

ID	Term
D008722	Methods
D008919	Investigative Techniques