HCCPhase 2NCT06413017
Nimotuzumab Combined With ICIs for the Treatment of Advanced Liver Cancer After First Line Treatment Failure
A Phase 2 study testing Nimotuzumab and ICIs(Immune checkpoint inhibitors) in people with HCC, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
This is a phase II, open-label, single-arm clinical study of nimotuzumab in combination with immune checkpoint inhibitors in patients with advanced liver cancer who have failed first-line therapy Read more about this study
- Who is it for?
- Ages 17 to 79 years
- Conditions the study is for
- HCC
- What is being tested?
- Nimotuzumab and ICIs(Immune checkpoint inhibitors)
- 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
- 31 Aug 2023to 31 Dec 2025
- 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 17 to 79 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects with histologically or cytologically confirmed advanced hepatocellular carcinoma (HCC), or The clinical diagnosis meets the American Association of Liver Diseases (AASLD) diagnostic criteria for hepatocellular carcinoma；
- Prior experience of targeted, immune, progression after conventional therapy, or intolerance (including TKIs,ICIs, chemotherapy, VEGF monoclonal antibody, or ICIs in combination with TKIs/VEGFs monoclonal antibody/chemotherapy)；
- Child-Pugh liver function rating within 7 days prior to the first dose of study drug: Grade A or better grade B (≤ 7 points) ;
- Phase B or C as assessed by BCLC; or Phase III as assessed by CNLC;
- Within 4 weeks prior to the first dose, at least one measurable target lesion remained according to mRECIST v1.1；
- EGFR postive and RAS wildtype；
Who cannot join
- Dignosised as hepatic cholangiocarcinoma, mixed cell carcinoma, or fibrolamellar cell carcinoma；
- History of hepatic encephalopathy within 6 months prior to the first dose of this study；
- Portal hypertension with endoscopic red signs, or those who are considered by the investigator to be at high risk of bleeding or who have had esophageal or gastric variceal bleeding within 6 months prior to the first dose；
- Symptomatic brain or meningeal metastases (unless patient is treated> 3 months, no evidence of progression on imaging within 4 weeks prior to treatment, and tumor-related clinical symptoms is stable)
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin
Chuntao Gao, MD, 022-2340123 ext. 3077, gaochuntao@tjmuch.com
About this study
Official title: Nimotuzumab Combined With Immune Checkpoint Inhibitors for the Treatment of Advanced Liver Cancer After First Line Treatment Failure ，a Prospective， Open Label，Single Arm，Phase II Trail
This is a phase II, open-label, single-arm clinical study of nimotuzumab in combination with immune checkpoint inhibitors in patients with advanced liver cancer who have failed first-line therapy
Read the detailed description
This study is a prospective, single-arm study, and plans to include 30 patients with hepatocellular carcinoma who do not respond to first-line therapy with a protoPD-1 (or PD-L1) inhibitor in combination with nimotuzumab in the posterior line, and receive nimotuzumab 400mg, D1, QW in combination with PD-1 (or PD-L1) inhibitor in the later line of treatment until disease progression and intolerable toxicity
- Conditions
- HCC
- Being tested
- Nimotuzumab, ICIs(Immune checkpoint inhibitors)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NimotuzumabDrug
Also called h-R3
Nimtuzumab：400mg,i.v.,once a week,until tumor progression、Death or untalerable toxicity
ICIs(Immune checkpoint inhibitors)Drug
Also called PD-1 or PD-L1
Use it as it is describe in the instructions from the specification
| Study group | Role | What they receive |
|---|---|---|
| Nimtuzumab combined ICIs | Experimental | Patients will be treated with nimotuzumab combined immune checkpoint inhibitors treatment Receives: Drug: Nimotuzumab; Drug: ICIs(Immune checkpoint inhibitors) |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR（Objtective reseponse rate）
（Objtective reseponse rate）
Measured: up to 24 month
Secondary outcomes (2)
OS（overall survival）
Time from the first dose to death
Measured: up to 24 month
PFS（pregression free survival）
time form fist dose to tumor progression or death
Measured: up to 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2024
- Study start31 Aug 2023
- Primary completion31 Jul 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 HCCStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and 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
- 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
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jihui Hao, Tianjin Medical University Cancer Institute and Hospital
- Investigators
- Jihui Hao, Dr, Study chair, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06413017
- Sponsor's protocol ID
- Nim-PC-7
- Status last verified
- May 2024
- First submitted
- 7 May 2024
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nimotuzumab Combined With Immune Checkpoint Inhibitors for the Treatment of Advanced Liver Cancer After First Line Treatment Failure ，a Prospective， Open Label，Single Arm，Phase II Trail
- ClinicalTrials.gov ID
- NCT06413017
- Acronym / sponsor ID
- Nim-PC-7
- Conditions
- HCC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 31 Aug 2023 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 14 May 2024 (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.
This is a phase II, open-label, single-arm clinical study of nimotuzumab in combination with immune checkpoint inhibitors in patients with advanced liver cancer who have failed first-line therapy
Detailed description
This study is a prospective, single-arm study, and plans to include 30 patients with hepatocellular carcinoma who do not respond to first-line therapy with a protoPD-1 (or PD-L1) inhibitor in combination with nimotuzumab in the posterior line, and receive nimotuzumab 400mg, D1, QW in combination with PD-1 (or PD-L1) inhibitor in the later line of treatment until disease progression and intolerable toxicity
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nimtuzumab combined ICIs | Experimental | Drug: Nimotuzumab, Drug: ICIs(Immune checkpoint inhibitors)Patients will be treated with nimotuzumab combined immune checkpoint inhibitors treatment |
Who may qualify
- Ages
- 17 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects with histologically or cytologically confirmed advanced hepatocellular carcinoma (HCC), or The clinical diagnosis meets the American Association of Liver Diseases (AASLD) diagnostic criteria for hepatocellular carcinoma；
- Prior experience of targeted, immune, progression after conventional therapy, or intolerance (including TKIs,ICIs, chemotherapy, VEGF monoclonal antibody, or ICIs in combination with TKIs/VEGFs monoclonal antibody/chemotherapy)；
- Child-Pugh liver function rating within 7 days prior to the first dose of study drug: Grade A or better grade B (≤ 7 points) ;
- Phase B or C as assessed by BCLC; or Phase III as assessed by CNLC;
- Within 4 weeks prior to the first dose, at least one measurable target lesion remained according to mRECIST v1.1；
Key exclusion criteria (4 listed)
- Dignosised as hepatic cholangiocarcinoma, mixed cell carcinoma, or fibrolamellar cell carcinoma；
- History of hepatic encephalopathy within 6 months prior to the first dose of this study；
- Portal hypertension with endoscopic red signs, or those who are considered by the investigator to be at high risk of bleeding or who have had esophageal or gastric variceal bleeding within 6 months prior to the first dose；
- Symptomatic brain or meningeal metastases (unless patient is treated> 3 months, no evidence of progression on imaging within 4 weeks prior to treatment, and tumor-related clinical symptoms is stable)
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 |
|---|---|---|
| NimotuzumabAlso: h-R3Nimtuzumab：400mg,i.v.,once a week,until tumor progression、Death or untalerable toxicity | Drug | Nimtuzumab combined ICIs |
| ICIs(Immune checkpoint inhibitors)Also: PD-1 or PD-L1Use it as it is describe in the instructions from the specification | Drug | Nimtuzumab combined ICIs |
Primary outcome
ORR（Objtective reseponse rate）
Time frame: up to 24 month
（Objtective reseponse rate）
2 secondary outcomes
OS（overall survival）
Time frame: up to 24 month
PFS（pregression free survival）
Time frame: up to 24 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- Individual participant dataSharing planned: No
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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.
Jihui Hao, Dr study chair
Tianjin Medical University Cancer Institute and Hospital
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 Nimotuzumab and ICIs(Immune checkpoint inhibitors) in people with HCC, run by Tianjin Medical University Cancer Institute and 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 6 inclusion and 4 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 14 May 2024. 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 Chuntao Gao, Dr (022-2340123 ext. 022-2340123, gaochuntao@tjmuch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR（Objtective reseponse rate） (time frame: up to 24 month). 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 14 May 2024.