Hepatocellular CarcinomaCCGLC-006NCT05520788
Ambispective Cohort Study of Precision Medicine for Primary Hepatobiliary Cancer Based on Next-generation Sequencing
An observational study of Hepatocellular Carcinoma and Biliary Tract Cancer, run by Tongji Hospital at 1 site in China.
Trial summary
Exploring the precise medicine of patients with primary hepatobiliary cancer. And evaluate the efficacy and safety of individualized treatment regimens for primary hepatobiliary cancer based on next-generation sequencing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma, Biliary Tract Cancer
- What is being tested?
- precise medicine
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2020to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed primary hepatobiliary cancer in Tongji Hospital, Wuhan with results of NGS tests.
Who may be able to join
- Age from 18 to 65, male or female.
- Radiologically and pathologically confirmed as hepatobiliary cancers with stage IV.
- Palliative care as the preferred.
- The result of next-generation sequencing (NGS) test show the patient has gene mutation and also can be treated by the right commercial products that have been approved by the China Food and Drug Administration (CFDA) or the Food and Drug Administration (FDA).
- ECOG performance status 0-2.
- Life expectancy ≥3 months.
- Agree to sign informed consent form.
Who cannot join
- Hepatobiliary cancer patient with stageI-III, or with any of the following items will not be eligible for screening. Such as, suitable for the treatment of radical resection, radical resection but evaluation unmeasurable.
- The result of NGS test show the patient has no gene mutation, or has gene mutation but no medicine.
- ECOG performance status ≥ 3.
- Female patients who are pregnant or not using a contraceptive method of birth control.
- History or presence of serious cardiovascular or cerebrovascular abnormalities.
- Abnormalities of the hepatic or renal functions, such as jaundice, ascites, bilirubin ≥ 1.5×ULN, alkaline phosphatase ≥ 3×ULN, persistent protein urine≥ grade 3 (according to National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTC-AE] v4.0), creatinine ratio > 3.5g/24 hours, renal failure.
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- Persistent infection > grade 2 (according to National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTC-AE] v4.0).
- Patient has underwent a major operation 4 weeks prior to screening or has not yet recovered from the operation.
- Patient with epilepsy, known or untreated brain metastases.
- The presence of wounds, ulcers or fractures that can not be healed, or with a past history of transplantation.
- The presence of bleeding events ≥grade 3 (according to National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTC-AE] v4.0) , present evidence or past history of coagulation dysfunction disorders.
- Known human immunodeficiency virus (HIV) infection history.
- Patient with drug abuse or unstable compliance.
- The presence of unresolved toxicity caused by any previous treatment/operation > grade 1 (according to National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTC-AE] v4.0), except alopecia, anemia or hypothyroidism).
- Investigator consider that the patient should not be enrolled in this study by careful assessment.
- The subjects participate in any other clinical trial in the meantime.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Hepatic Surgery Center, Tongji Hospital, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Ze-yang Ding, M.D., +8613407156200, dingzyang@sina.com
About this study
Exploring the precise medicine of patients with primary hepatobiliary cancer. And evaluate the efficacy and safety of individualized treatment regimens for primary hepatobiliary cancer based on next-generation sequencing.
Read the detailed description
The purpose of this study is to explore the precise treatment in hepatobiliary cancer patients and evaluate drug efficacy, progression free and overall survival. This trial study is based on genetic tests, then therapeutic target drugs are administered according to the genetic test reports. Patients with genetic abnormalities (such as mutations, amplifications, or translocations) may benefit from precise treatment which targets particular genetic abnormality. The identifications of these genetic abnormalities may help treat hepatobiliary cancer patients.
The genetic tests are performed for the eligible subjects in this study, then therapeutic target drugs are administered according to the genetic test reports. While the precise treatments, follow-ups are conducted to evaluate the efficacy and safety of the target drugs for the subjects, until the overall survival.
- Conditions
- Hepatocellular Carcinoma, Biliary Tract Cancer
- Being tested
- precise medicine
- Keywords
- Liver Neoplasms, Biliary Tract Neoplasms, NGS
- Medical subject headings
- Carcinoma, Hepatocellular, Biliary Tract Neoplasms, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
precise medicineGenetic
During screening stage, all patients should accept next-generation sequencing (NGS) test.
| Study group | Role | What they receive |
|---|---|---|
| Precise medicine | All patients should accept next-generation sequencing (NGS) test before treatment. Receives: Genetic: precise medicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
Time of progression will be obtained by telephone interview or medical treatment records.
Measured: From treatment initiation for advanced or metastatic HCC to the first date of disease progression for any cause up to 2 year
Secondary outcomes (6)
Overall Survival (OS)
Include all-cause death of patients in this study.
Measured: 2 years
Objective response rates (ORR)
Percentage of patients whose tumors have a complete or partial response to treatment.
Measured: From treatment initiation to CR or PR, up to 2 years
Disease Control Rate (DCR)
The proportion of patients who had either stable disease (SD) for ≥ 6 months, a CR or PR after initiation of treatment for HCC
Measured: From treatment initiation to SD, CR or PR, up to 2 years
Duration of Response (DOR)
duration from the first assessment of the tumor was CR or PR to the time that the first assessment for PD or date of death from any cause
Measured: From treatment initiation to PD, up to 2 years
Adverse Drug Reaction (ADR)/Adverse Event (AE)
Patients with treatment-related adverse events as assessed by CTCAE v4.0.
Measured: Through study completion, an average of 2 years.
Quality of Life (QoL) after treatment
The life quality of every subject will be assessed every 3 months according to the FACT-Hep questionnaire, which assesses generic HRQL concerns and disease-specific issues.
Measured: Through study completion, an average of 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2022
- Study start1 May 2020
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ze-yang Ding, MD, Tongji Hospital
- Investigators
- Wanguang Zhang, Study chair, Tongji HospitalZeyang Ding, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05520788
- Sponsor's protocol ID
- TJ-IRB20220129
- Acronym
- CCGLC-006
- Status last verified
- Jan 2025
- First submitted
- 28 Aug 2022
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data have the gene mutations information of patients.
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ambispective Cohort Study of Precision Medicine for Primary Hepatobiliary Cancer Based on Next-generation Sequencing
- ClinicalTrials.gov ID
- NCT05520788
- Acronym / sponsor ID
- CCGLC-006 / TJ-IRB20220129
- Conditions
- Hepatocellular Carcinoma, Biliary Tract Cancer
- Keywords
- Liver Neoplasms, Biliary Tract Neoplasms, NGS
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 30 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Exploring the precise medicine of patients with primary hepatobiliary cancer. And evaluate the efficacy and safety of individualized treatment regimens for primary hepatobiliary cancer based on next-generation sequencing.
Detailed description
The purpose of this study is to explore the precise treatment in hepatobiliary cancer patients and evaluate drug efficacy, progression free and overall survival. This trial study is based on genetic tests, then therapeutic target drugs are administered according to the genetic test reports. Patients with genetic abnormalities (such as mutations, amplifications, or translocations) may benefit from precise treatment which targets particular genetic abnormality. The identifications of these genetic abnormalities may help treat hepatobiliary cancer patients.
The genetic tests are performed for the eligible subjects in this study, then therapeutic target drugs are administered according to the genetic test reports. While the precise treatments, follow-ups are conducted to evaluate the efficacy and safety of the target drugs for the subjects, until the overall survival.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Precise medicine | – | Genetic: precise medicineAll patients should accept next-generation sequencing (NGS) test before treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed primary hepatobiliary cancer in Tongji Hospital, Wuhan with results of NGS tests.
Key inclusion criteria (7 listed)
- Age from 18 to 65, male or female.
- Radiologically and pathologically confirmed as hepatobiliary cancers with stage IV.
- Palliative care as the preferred.
- The result of next-generation sequencing (NGS) test show the patient has gene mutation and also can be treated by the right commercial products that have been approved by the China Food and Drug Administration (CFDA) or the Food and Drug Administration (FDA).
- ECOG performance status 0-2.
Key exclusion criteria (16 listed)
- Hepatobiliary cancer patient with stageI-III, or with any of the following items will not be eligible for screening. Such as, suitable for the treatment of radical resection, radical resection but evaluation unmeasurable.
- The result of NGS test show the patient has no gene mutation, or has gene mutation but no medicine.
- ECOG performance status ≥ 3.
- Female patients who are pregnant or not using a contraceptive method of birth control.
- History or presence of serious cardiovascular or cerebrovascular abnormalities.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| precise medicineDuring screening stage, all patients should accept next-generation sequencing (NGS) test. | Genetic | Precise medicine |
Primary outcome
Progression-free survival (PFS)
Time frame: From treatment initiation for advanced or metastatic HCC to the first date of disease progression for any cause up to 2 year
Time of progression will be obtained by telephone interview or medical treatment records.
6 secondary outcomes
Overall Survival (OS)
Time frame: 2 years
Objective response rates (ORR)
Time frame: From treatment initiation to CR or PR, up to 2 years
Disease Control Rate (DCR)
Time frame: From treatment initiation to SD, CR or PR, up to 2 years
Duration of Response (DOR)
Time frame: From treatment initiation to PD, up to 2 years
Adverse Drug Reaction (ADR)/Adverse Event (AE)
Time frame: Through study completion, an average of 2 years.
Quality of Life (QoL) after treatment
Time frame: Through study completion, an average of 2 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2025.
- Individual participant dataSharing planned: No. The data have the gene mutations information of patients.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wanguang Zhang study chair
Tongji Hospital
Zeyang Ding principal investigator
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma and Biliary Tract Cancer, run by Tongji Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bixiang Zhang, PhD (86-027-83665293, bixiangzhang@hust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: From treatment initiation for advanced or metastatic HCC to the first date of disease progression for any cause up to 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2025.