a Prospective Registration Study for Patients With Advanced Refractory Solid Tumors

December 14, 2021 updated by: The University of Hong Kong-Shenzhen Hospital

Patients With Advanced Refractory Solid Tumors Who Failed Standard Treatments and Matched Individualized Treatment Based on Tumor Molecular Characteristics: a Prospective Registration Study

This is a prospective registration study for patients with advanced refractory solid tumors. Patients who meet the eligibility criteria will be included to participate in the study, and baseline information to be collected after signed informed consent. Patients will choose for themselves whether to carry out targeted therapy or other appropriate treatment methods. And we plan to follow up for at least 12 months or until disease progression or death.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

  1. Screen and enroll 120 patients with refractory solid tumors, and sign informed consents;
  2. Extract the clinical data, including gender, age, disease diagnosis, past treatment history and genetic test results, etc.;
  3. Take biopsy samples and perform NGS testing on patients. After discussion by the Molecular Steering Committee (MTB), the recommendations for treatment guidance will be given based on treatment guidelines and clinical experience;
  4. The patient and the clinician jointly select the treatment plan and follow-up until the patient's disease progresses. The follow-up time will be 1 year;
  5. During the follow-up period, clinical treatment and routine examination information of patients will be collected;
  6. If the patient fails to receive molecular targeted therapy or they cannot tolerate the adverse reaction of the drug after adequate treatment, the clinician will evaluate whether a second NGS resistance test is needed or the participant may withdraw from the study.

Study Type

Observational

Enrollment (Anticipated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

From November 2021 to November 2022, the patients with refractory tumors who underwet the standard treatment standard treatment, went to the Shenzhen Hospital of the University of Hong Kong and were willing to have genetic testing for individualized targeted therapy. It is planned to enroll 120 patients.

Description

Inclusion Criteria:

  • Recurrent or metastatic malignant solid tumor confirmed by histology or cytology
  • Disease progression or intolerance after receiving standard treatment
  • With evaluable lesions (RECIST 1.1 standard)
  • Tumor tissue pieces with sufficient formalin-fixed paraffin-embedded (FFPE) can be used for genetic testing
  • ECOG PS score 0-4 (3-4 points only for patients with tumor burden)
  • Sign the informed consent form

Exclusion Criteria:

  • The subject is participating in any other clinical research;
  • Researchers believe that serious or uncontrolled medical diseases (ie uncontrolled diabetes, chronic kidney disease, chronic lung disease, or uncontrolled active infections, mental illnesses/social conditions that restrict compliance with research requirements) that will confuse the analysis of research treatment response ；
  • Patients during pregnancy or lactation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: 2021.11-2023.11
ORR is judged based on RECIST 1.1 criteria for all treatment groups at each visit period.
2021.11-2023.11
Proportion of targeted therapy guided by tumor molecular characteristics
Time Frame: 2021.11-2023.11
The proportion of all enrolled patients receiving targeted therapy guided by tumor molecular characteristics during the study period, would be calculated, which defined as having received one or more the treatments based on tumor molecular characteristics.
2021.11-2023.11

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS)
Time Frame: 2021.11-2023.11
PFS is defined as the time from the first administration to disease progression or death.
2021.11-2023.11
Overall survival (OS)
Time Frame: 2021.11-2023.11
OS is defined as the time from the first administration to death from any cause.
2021.11-2023.11
Best overall response (BOR)
Time Frame: 2021.11-2023.11
The effectiveness of a patient would be evaluated multiple times, and the best one is defined as the best overall response.
2021.11-2023.11
Adverse events
Time Frame: 2021.11-2023.11
The incidence of serious adverse events in each group, which is judged based on CTCAE v5.0 standard.
2021.11-2023.11
Quality of Life Score (QoL)
Time Frame: 2021.11-2023.11
The QoL is evaluated by the scale (0PROMIS-29 Profile v2.1) at each visit period for all the enrolled patients.
2021.11-2023.11
Proportion of patients with intervening genomic variants
Time Frame: 2021.11-2023.11
The intervening genomic variants are defined by the conclusion after MTB discussion.
2021.11-2023.11

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in ECOG score before and after treatment
Time Frame: 2021.11-2023.11
We compare the ECOG scores of each visit with the baseline, including the number and proportion, and the difference.
2021.11-2023.11
Proportion of targeted therapy guided by second tumor molecular characteristics
Time Frame: 2021.11-2023.11
After targeted therapy drug resistance, then the proportion of targeted therapy guided by the second tumor molecular characteristics would be calculated during study period.
2021.11-2023.11

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong-Shenzhen Hospital

Collaborators

Tianjin Happy Life Technology Co., Ltd.

Investigators

  • Principal Investigator: Yongmei Li, MD, The University of Hong Kong-Shenzhen Hospital
  • Principal Investigator: Weitang Wu, The University of Hong Kong-Shenzhen Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 30, 2021

Primary Completion (Anticipated)

December 30, 2023

Study Completion (Anticipated)

March 30, 2024

Study Registration Dates

First Submitted

November 24, 2021

First Submitted That Met QC Criteria

December 14, 2021

First Posted (Actual)

January 4, 2022

Study Record Updates

Last Update Posted (Actual)

January 4, 2022

Last Update Submitted That Met QC Criteria

December 14, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • v1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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