Hepatocellular CancerPhase 2NCT05453383
Clinical Recruitment of Patients With First-line Targeted Drug Resistance or Intolerance to Hepatocellular Cancer With PD-1 Inhibitor (Toripalimab,JS001) Detected on the NGS Platform Combined With Anlotinib
A Phase 2 study testing Anlotinib;Toripalimab in people with Hepatocellular Cancer, run by Shen Feng at 1 site in China.
Trial summary
PD-1 inhibitors have become the standard treatment for advanced hepatocellular cancer, while targeted drugs such as sorafenib and lenvatinib are the first-line standard treatment for hepatocellular cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Cancer
- What is being tested?
- Anlotinib;Toripalimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 8 Jul 2022to 31 Dec 2022
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological or cytological diagnosis of hepatocellular cancer;
- At least one measurable lesion was assessed according to RECIST1.1 criteria.
- Age from 18 to 75,ECOG physical strength score reaches 0-2;
- After first-line targeted therapy, it was assessed as advanced or intolerant according to RECIST1.1 criteria.
- Child-pugh grade A or B for liver function;
- Bone marrow function was basically normal: neutrophils > 1.5x 10^9/L, platelets > 75 x10^9/L;
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- Adequate renal reserve: creatinine <130 mol/L;
- Centerless dysfunction, chest pain (medically uncontrollable), no myocardial infarction within 12 months prior to study initiation;
- Estimated survival ≥3 months;
- Signed the informed consent.
Who cannot join
- Previous application of PD-1 inhibitor and anlotinib;
- Secondary malignant tumors or other tumors (except superficial skin cancer and localized low-grade malignant tumors) occurring within 3 years prior to the start of the study;
- Metastasis of the brain or meninges;
- Imaging findings indicated that the tumor was involved in important blood vessels or that the researchers had assessed that it might lead to fatal bleeding during follow-up;
- Bleeding events at any site ≥CTCAE level 3 occurred 4 weeks before medication, and there were unhealed wounds, ulcers or fractures;
- The time of occurrence of arteriovenous thrombosis, such as cerebrovascular accident, deep vein thrombosis and pulmonary embolism, within 6 months before enrollment;
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- Untreated intestinal obstruction or subobstruction that cannot eat or affect systemic administration;
- Patients with active infection or other possible disorders receive inflammatory infections under planned management;
- Have a history of uncontrolled substance abuse or mental disorders;
- In the judgment of the investigator, patients with concomitant diseases that may seriously endanger their own safety or may affect the completion of the study;
- Participated in other clinical trials;
- Pregnant and nursing women;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Eastern hepatobilliary surgery hospital
Shanghai, Shanghai Municipality, 200438
Shen Feng, MD, 0086-021-25070805, shenfengdfgd@yahoo.com.cn
Wu Dong, MD, 0086-021-25070765, wuyuz@yahoo.com.cn
About this study
PD-1 inhibitors have become the standard treatment for advanced hepatocellular cancer, while targeted drugs such as sorafenib and lenvatinib are the first-line standard treatment for hepatocellular cancer. Recent studies have shown that PD-1 inhibitors combined with targeted drugs can improve the efficacy of hepatocellular cancer.To clear the joint treatment in patients with advanced hepatocellular cancer (HCC) efficacy and evaluate its safety, we proposed to carry out the PD - 1 inhibitor (Toripalimab, JS001) joint anti-angiogenesis small molecules targeting drug anlotinib for clinical research,at the same time, based on joint solution of NGS platform testing to predict the curative effect, bring benefit for the long-term survival of patients with hepatocellular cancer (HCC).
- Conditions
- Hepatocellular Cancer
- Being tested
- Anlotinib;Toripalimab
- Keywords
- Antotinib Toripalimab
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anlotinib;ToripalimabDrug
Also called AL3818;JS001
Anlotinib Hydrochloride;Toripalimab injiection
| Study group | Role | What they receive |
|---|---|---|
| Anlotinib and Toripalimab treatment | Experimental | Anlotinib Hydrochloride and Toripalimab Injection Receives: Drug: Anlotinib;Toripalimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
Objective response rate include response from stable disease to complete
Measured: at least 2 months
Secondary outcomes (1)
Progression-free survival
The time between the start of randomization and tumorigenesis or death
Measured: at least 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2022
- Study start8 Jul 2022 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CancerStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shen Feng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shen Feng, Eastern Hepatobiliary Surgery Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05453383
- Sponsor's protocol ID
- EHBH-201908
- Status last verified
- Jul 2022
- First submitted
- 7 Jul 2022
- Last updated
- 12 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Recruitment of Patients With First-line Targeted Drug Resistance or Intolerance to Hepatocellular Cancer With PD-1 Inhibitor (Toripalimab,JS001) Detected on the NGS Platform Combined With Anlotinib
- ClinicalTrials.gov ID
- NCT05453383
- Acronym / sponsor ID
- EHBH-201908
- Conditions
- Hepatocellular Cancer
- Keywords
- Antotinib Toripalimab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shen FengUniversity, hospital or other
- Study start
- 8 Jul 2022 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 12 Jul 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.
PD-1 inhibitors have become the standard treatment for advanced hepatocellular cancer, while targeted drugs such as sorafenib and lenvatinib are the first-line standard treatment for hepatocellular cancer. Recent studies have shown that PD-1 inhibitors combined with targeted drugs can improve the efficacy of hepatocellular cancer.To clear the joint treatment in patients with advanced hepatocellular cancer (HCC) efficacy and evaluate its safety, we proposed to carry out the PD - 1 inhibitor (Toripalimab, JS001) joint anti-angiogenesis small molecules targeting drug anlotinib for clinical research,at the same time, based on joint solution of NGS platform testing to predict the curative effect, bring benefit for the long-term survival of patients with hepatocellular cancer (HCC).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anlotinib and Toripalimab treatment | Experimental | Drug: Anlotinib;ToripalimabAnlotinib Hydrochloride and Toripalimab Injection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histological or cytological diagnosis of hepatocellular cancer;
- At least one measurable lesion was assessed according to RECIST1.1 criteria.
- Age from 18 to 75,ECOG physical strength score reaches 0-2;
- After first-line targeted therapy, it was assessed as advanced or intolerant according to RECIST1.1 criteria.
- Child-pugh grade A or B for liver function;
Key exclusion criteria (12 listed)
- Previous application of PD-1 inhibitor and anlotinib;
- Secondary malignant tumors or other tumors (except superficial skin cancer and localized low-grade malignant tumors) occurring within 3 years prior to the start of the study;
- Metastasis of the brain or meninges;
- Imaging findings indicated that the tumor was involved in important blood vessels or that the researchers had assessed that it might lead to fatal bleeding during follow-up;
- Bleeding events at any site ≥CTCAE level 3 occurred 4 weeks before medication, and there were unhealed wounds, ulcers or fractures;
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 |
|---|---|---|
| Anlotinib;ToripalimabAlso: AL3818;JS001Anlotinib Hydrochloride;Toripalimab injiection | Drug | Anlotinib and Toripalimab treatment |
Primary outcome
Objective response rate
Time frame: at least 2 months
Objective response rate include response from stable disease to complete
1 secondary outcome
Progression-free survival
Time frame: at least 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anlotinib;Toripalimab in people with Hepatocellular Cancer, run by Shen Feng 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 10 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 12 Jul 2022. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Zhengang Yuan, Ph.D (00862181887451, yuanzg@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: at least 2 months). 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 12 Jul 2022.