Advanced Hepatocellular CarcinomaNCT04101747
To Explore the Diversity of Intestinal Flora in Patients With Advanced HCC Combin ed With Anti-PD-1 and Targeted Drug Therapy and the Correlation Between Metabolites and Therapeutic Effect
An observational study of Advanced Hepatocellular Carcinoma, run by Sun Yat-sen University.
Trial summary
The study is to explore the correlation between intestinal flora diversity and meta bolites in patients with advanced lver cancer rceiving Anti-PD-1 combined target-ed drug therapy,so that to get the analysis of intestinal flora of PD-1 inhibitors in liver cancer. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Advanced Hepatocellular Carcinoma
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2019to 30 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Include patients who meet the entry and discharge criteria, obtain patients'clinical data, pathological and case data, enter the database, collect fecal samples of 5-10g, evaluate the response to treatment every 6 weeks, and conduct data analysis, compare the baseline intestinal microflora diversity between and within groups, microflora diversity mapping, continuous Shannon fingers. Number curve mapping, attention to follow-up patients, record treatment, progress, other toxic and side effects and combined drug use information.
Who may be able to join
- Patients signed informed voluntary enrollment and expected survival of more than 12 weeks;
- Patients with HCC confirmed by histopathology or cytology or clinic are HBV-related HCC;
- No systematic treatment for HCC has been received in the past, excluding local chemotherapy drugs used in TACE/TAI;
- Not suitable for surgical treatment;
- Child-Pugh Class: Grade A or B (≤7 points);
- BCLC stage C;
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- ECOG PS≤1;
- At least one measurable lesion (according to RECIST v1.1 requirement, the length of spiral CT of the lesion is ≥10mm or the short diameter of enlarged lymph nodes is ≥15 mm);
- Organ Function Requirements (within 7 days before treatment):
- Blood routine examination: WBC (>1.5 109/L); PLT (>75 109/L); HB (>90 g/L); no blood transfusion within 14 days before screening, G-CSF drug correction) Liver function tests: ALB (> 29 g/L); TBiL (< 1.5 ULN); ALT, AST, AKP (< 5 ULN); INR (< 2.3) or PT (< 6 seconds) exceeding normal control Renal function: Cr < 1.5 ULN or CCr > 50 mL/min
- Patients with active hepatitis B virus (HBV) infection: must receive anti HBV treatment;
- Fertility women should abstinence or use reliable methods of contraception during the observation of curative effect. Serum HCG test must be negative within 7 days before the study treatment, and must be non-lactating. When it comes to abstinence, partners should also have reliable and effective contraception;
- Assessment of patients who are eligible for anti-PD-1 combined with targeted drug therapy;
- Consent to sign informed consent and follow up for a long time.
Who cannot join
- Known hepatocholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma and lamellar cell carcinoma; other active malignant tumor except HCC within 5 years or simultaneously;
- Patients with moderate or severe ascites need therapeutic puncture and drainage or Child score > 2 (except those with small amount of ascites without clinical symptoms);
- Patients with a history of gastrointestinal bleeding or risk of bleeding within 6 months before the start of the study, such as severe esophageal varices, locally active gastrointestinal ulcer lesions, and positive persistent fecal occult blood;
- Known hereditary or acquired bleeding or thrombotic tendency, thrombosis or embolism occurred within 6 months before treatment, and aspirin > 325 mg/day was taken within 10 days before treatment;
- It is known that there is a history of severe allergy to any monoclonal antibody or anti-angiogenesis targeted drug;
- Severe infections occurred within 4 weeks before the start of the study, including but not limited to hospitalization due to infections, bacteremia or complications of severe pneumonia;
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- Previous treatment with other anti-PD-1 antibodies or other immunotherapy against PD-1/PD-L1;
- Complicated with other hepatitis virus infection or alcoholic liver disease, hereditary metabolic liver disease, autoimmune liver disease and other liver diseases;
- Congenital or acquired immunodeficiency (HIV, or treatment with immunosuppressive agents or systemic hormones within 14 days before treatment (>10mg/d prednisone or other hormones)
- There are cardiopulmonary diseases that can not be well controlled, such as cardiac insufficiency above NYHA II or LVEF < 50% by color Doppler echocardiography, COPD with repeated pulmonary infections.
- Intravenous antibiotics or prophylactic antibiotics were given in the past month. -Receive immunopotentiation therapy, such as thymosin, Ridaxian, etc.
- Other factors that may affect the results of the study or lead to the forced termination of the study, such as alcoholism, drug abuse, other serious diseases (including mental disorders) requiring combined treatment, accompanied by family or social factors, may affect patient safety.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: To Explore the Diversity of Intestinal Flora in Patients With Advanced Hepatocellular Carcinoma Receiving Anti-PD-1 Combined With Targeted Drug Therapy and the Correlation Between Metabolites and Therapeutic Effect:A Multi-Center Study
The study is to explore the correlation between intestinal flora diversity and meta bolites in patients with advanced lver cancer rceiving Anti-PD-1 combined target-ed drug therapy,so that to get the analysis of intestinal flora of PD-1 inhibitors in liver cancer.
Read the detailed description
The combination of PD-1/PD-L1 inhibitors and targeted drugs as a promising strategy for the treatment of hepatocellular carcinoma has a breakthrough significance for the treatment of some advanced and refractory tumors.However,studies have shown that intestinal flora diversity indicates a good prognosis of PD-1/PD-L1 inhibitors in the treatment of non-small cell lung cancer, the intestinal flora analysis of PD-1 inhibitors in hepatocellular carcinoma is still a new field to be explored.
This study is to select patients who meet the criteria of entry and discharge, sign informed consent, obtain patients'clinical data, pathological and case data, and enter the database. Before the treatment of PD-1 (no more than 24 hours), during the treatment of PD-1 (every time before treatment, three weeks, a total of 11 follow-up visits), at the end of treatment, fecal samples were collected in sterile containers for 5-10g, and feces were stored at 4 degrees C, frozen at - 80 degrees C within 24 hours; the response to treatment was evaluated every 6 weeks, and the disease was first evaluated clinically. The patients were divided into response group (R) (partial response or stable condition) or non-response group (NR) (disease progression) according to RECIST 1.1 evaluation criteria. Subgroup had high diversity of bacteria and low diversity of bacteria, and were observed continuously until the end of treatment. The bacterial ribosomal DNA was extracted, metabolites were detected and flow cytometry was used to analyze the data. The baseline intestinal microflora diversity, microflora diversity mapping, continuous Shannon index curve change mapping were compared between groups and within groups, and correlation validation was carried out.
- Conditions
- Advanced Hepatocellular Carcinoma
- Keywords
- Advanced hepatocellular carcinoma, Combination of PD-1/PD-L1 Inhibitors and Targeted Drugs, Diversity of intestinal flora, Metabolites
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (RR)
To analyse the Objective response rate (RR) of patients with advanced HCC receiving anti-PD-1 combined with targeted drug therapy
Measured: Up to approximately 3 years
Disease control rate (DCR)
To exprole the Disease control rate (DCR) of patients with advanced HCC receiving anti-PD-1 combined with targeted drug therapy
Measured: Up to approximately 3 years
Number of intestinal flora
To exprole the Number of intestinal flora of patients with advanced HCC receiving anti-PD-1 combined with targeted drug therapy
Measured: Up to approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2019
- Study start1 Nov 2019 (estimated)
- Primary completion30 Nov 2022 (estimated)
- Study completion30 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, First Affiliated Hospital, Sun Yat-Sen University
- Responsible party
- Principal investigator, Chan Xie, Sun Yat-sen University
- Investigators
- Chan Xie, Professor, Principal investigator, The Third Affliated Hosoital of Sun Yat-Sun University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04101747
- Sponsor's protocol ID
- XC2
- Status last verified
- Aug 2019
- First submitted
- 22 Sep 2019
- Last updated
- 24 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Explore the Diversity of Intestinal Flora in Patients With Advanced Hepatocellular Carcinoma Receiving Anti-PD-1 Combined With Targeted Drug Therapy and the Correlation Between Metabolites and Therapeutic Effect:A Multi-Center Study
- ClinicalTrials.gov ID
- NCT04101747
- Acronym / sponsor ID
- XC2
- Conditions
- Advanced Hepatocellular Carcinoma
- Keywords
- Advanced hepatocellular carcinoma, Combination of PD-1/PD-L1 Inhibitors and Targeted Drugs, Diversity of intestinal flora, Metabolites
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, First Affiliated Hospital, Sun Yat-Sen University
- Study start
- 1 Nov 2019 (estimated)
- Primary completion
- 30 Nov 2022 (estimated)
- Study completion
- 30 Nov 2022 (estimated)
- First posted
- 24 Sep 2019 (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.
The study is to explore the correlation between intestinal flora diversity and meta bolites in patients with advanced lver cancer rceiving Anti-PD-1 combined target-ed drug therapy,so that to get the analysis of intestinal flora of PD-1 inhibitors in liver cancer.
Detailed description
The combination of PD-1/PD-L1 inhibitors and targeted drugs as a promising strategy for the treatment of hepatocellular carcinoma has a breakthrough significance for the treatment of some advanced and refractory tumors.However,studies have shown that intestinal flora diversity indicates a good prognosis of PD-1/PD-L1 inhibitors in the treatment of non-small cell lung cancer, the intestinal flora analysis of PD-1 inhibitors in hepatocellular carcinoma is still a new field to be explored.
This study is to select patients who meet the criteria of entry and discharge, sign informed consent, obtain patients'clinical data, pathological and case data, and enter the database. Before the treatment of PD-1 (no more than 24 hours), during the treatment of PD-1 (every time before treatment, three weeks, a total of 11 follow-up visits), at the end of treatment, fecal samples were collected in sterile containers for 5-10g, and feces were stored at 4 degrees C, frozen at - 80 degrees C within 24 hours; the response to treatment was evaluated every 6 weeks, and the disease was first evaluated clinically. The patients were divided into response group (R) (partial response or stable condition) or non-response group (NR) (disease progression) according to RECIST 1.1 evaluation criteria. Subgroup had high diversity of bacteria and low diversity of bacteria, and were observed continuously until the end of treatment. The bacterial ribosomal DNA was extracted, metabolites were detected and flow cytometry was used to analyze the data. The baseline intestinal microflora diversity, microflora diversity mapping, continuous Shannon index curve change mapping were compared between groups and within groups, and correlation validation was carried out.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Include patients who meet the entry and discharge criteria, obtain patients'clinical data, pathological and case data, enter the database, collect fecal samples of 5-10g, evaluate the response to treatment every 6 weeks, and conduct data analysis, compare the baseline intestinal microflora diversity between and within groups, microflora diversity mapping, continuous Shannon fingers. Number curve mapping, attention to follow-up patients, record treatment, progress, other toxic and side effects and combined drug use information.
Key inclusion criteria (14 listed)
- Patients signed informed voluntary enrollment and expected survival of more than 12 weeks;
- Patients with HCC confirmed by histopathology or cytology or clinic are HBV-related HCC;
- No systematic treatment for HCC has been received in the past, excluding local chemotherapy drugs used in TACE/TAI;
- Not suitable for surgical treatment;
- Child-Pugh Class: Grade A or B (≤7 points);
Key exclusion criteria (12 listed)
- Known hepatocholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma and lamellar cell carcinoma; other active malignant tumor except HCC within 5 years or simultaneously;
- Patients with moderate or severe ascites need therapeutic puncture and drainage or Child score > 2 (except those with small amount of ascites without clinical symptoms);
- Patients with a history of gastrointestinal bleeding or risk of bleeding within 6 months before the start of the study, such as severe esophageal varices, locally active gastrointestinal ulcer lesions, and positive persistent fecal occult blood;
- Known hereditary or acquired bleeding or thrombotic tendency, thrombosis or embolism occurred within 6 months before treatment, and aspirin > 325 mg/day was taken within 10 days before treatment;
- It is known that there is a history of severe allergy to any monoclonal antibody or anti-angiogenesis targeted drug;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Objective response rate (RR)
Time frame: Up to approximately 3 years
To analyse the Objective response rate (RR) of patients with advanced HCC receiving anti-PD-1 combined with targeted drug therapy
Disease control rate (DCR)
Time frame: Up to approximately 3 years
To exprole the Disease control rate (DCR) of patients with advanced HCC receiving anti-PD-1 combined with targeted drug therapy
Number of intestinal flora
Time frame: Up to approximately 3 years
To exprole the Number of intestinal flora of patients with advanced HCC receiving anti-PD-1 combined with targeted drug therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2019.
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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. This study is not recruiting at the moment.
Chan Xie, Professor principal investigator
The Third Affliated Hosoital of Sun Yat-Sun University
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Hepatocellular Carcinoma, run by Sun Yat-sen University.
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 14 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 24 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chan Xie, Professor (8620-85252043, happyxiechan@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (RR) (time frame: Up to approximately 3 years). The study lists 3 primary outcomes in all. 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 24 Sep 2019.