Hepatic CarcinomaPhase 1/2NCT04538313
A Clinical Study in Patients With High-risk Recurrent Primary Hepatocellular Carcinoma Using Autologous TILs
A Phase 1/2 study testing Tumor infiltrating lymphocyte in people with Hepatic Carcinoma, run by CAR-T (Shanghai) Cell Biotechnology Co., Ltd. at 1 site in China.
Trial summary
Early clinical trials on evaluating the tolerance, safety and efficacy of autologous TILs in high-risk recurrent primary hepatocellular carcinoma Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatic Carcinoma
- What is being tested?
- Tumor infiltrating lymphocyte
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 26 Aug 2020to 31 Oct 2022
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years, gender unlimited;
- Patients diagnosis of primary hepatocellular carcinoma by histopathology and/or cytology;
- At the initial enrollment evaluation, patients were expected to accept radical resection of liver cancer and meet at least one of the following high-risk recurrence factors after surgery: ①There are 3 or more tumor lesions in the liver; ②The diameter of a single tumor lesion is >8cm; ③Existence macrovascular tumor thrombus; ④>5 MVI or MVI occurred in the distant paracancer tissues;
- Before enrollment (after radical resection of liver cancer), imaging evaluation was performed to ensure that the tumor was completely removed (clear margin);
- Must have at least 1 resectable lesion (diameter ≥2 cm);
- ECOG score <2;
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- Child-Pugh score ≤7;
- Hematology and organ function indicators should be met simultaneously: (1) White blood cell count ≥3.0E+9/ L, neutrophil count ≥1.5E+9/ L, platelet countPlatelet count ≥8.0E10/ L, hemoglobin ≥80g/L (2) Liver function: aspartate aminotransferase (AST)≤5 times normal value, alanine aminotransferase (ALT)≤5 times normal value, bilirubin ≤5 times normal value, serum albumin ≥28 g/L; (3) Renal function: creatinine (Cr)≤1.5 times normal limit, creatinine clearance ≥50 mL/min;
- An estimated life expectancy of ≥3 months;
- Participation in this clinical study voluntary, can cooperate with researchers to carry out research, and sign informed consent.
Who cannot join
- Primary hepatocellular carcinoma (HCC) has recurred in the past, or has other types of liver cancer at the same time (such as intrahepatic cholangiocarcinoma, mixed type of liver cancer);
- Have a history of high fever or severe infection within 2 weeks prior to pretreatment, or are expected to undergo systemic anti-infective therapy or systemic steroid therapy during this trial;
- Hepatic encephalopathy occurred within 2 weeks before pretreatment;
- Previous or screening with autoimmune liver disease;
- Screening with moderate or higher peritoneal effusion;
- Clear neurological/psychiatric symptoms are known to be associated with brain metastases and/or assessed by MMSE;
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- Anti-tumor therapy such as chemotherapeutic drugs, targeted drugs, radio frequency ablation or minimally invasive intervention was received within 4 weeks before pretreatment;
- Have received or are expected to participate in this study within 4 weeks before pretreatment to receive TIL required focus radiotherapy, or tumor evaluation focus (target focus or non-target focus) radiotherapy, or radical radiotherapy;
- Any toxic response resulting from previous anti-tumor treatment prior to pretreatment did not return to grade 1 or below (CTCAE5.0 version);
- Previous history of organ / stem cell transplantation or expected to be involved in this trial for organ / stem cell transplantation;
- Left ventricular ejection fraction (LVEF)<45% or New York Heart Association (NYHA)≥ grade 2;
- Known or private HIV infection or syphilis infection;
- The previous 3 years other system primary malignant tumor history (except skin basal cell carcinoma or cervical carcinoma in situ);
- A known allergy to two or more non-homogeneous foods/drugs, or a known history of allergies to pre-treated drugs, including cyclophosphamide, fludarbin, interleukin;
- Pregnant, lactating women or within one year of having a family plan;
- Participated in other clinical trials within 3 months prior to screening;
- Other circumstances that the researchers considered inappropriate to participate in the experiment.
Trial locations and contacts
1 site in 1 country.
China1 site
Eastern Hepatobiliary Surgery Hospital
Shanghai, Shanghai Municipality, 200438
About this study
Official title: Early Clinical Trials on Evaluating the Tolerance, Safety and Efficacy of Autologous TILs in High-risk Recurrent Primary Hepatocellular Carcinoma
Early clinical trials on evaluating the tolerance, safety and efficacy of autologous TILs in high-risk recurrent primary hepatocellular carcinoma
- Conditions
- Hepatic Carcinoma
- Being tested
- Tumor infiltrating lymphocyte
- Keywords
- TIL; HCC; clinical research
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tumor infiltrating lymphocyteDrug
Tumor infiltrating lymphocytes were isolated from tumor tissues from tumor biopsy or operation. These TILs were cultured in human IL-2 medium for 4 to 5 weeks. 10e9 to 10e10 TILs were yielded. The phenotype, function and sterile were detected before these TILs infused patients.
| Study group | Role | What they receive |
|---|---|---|
| High dose group | Experimental | 10^10 TIL Receives: Drug: Tumor infiltrating lymphocyte |
| Low dose group | Experimental | 10^9 TIL Receives: Drug: Tumor infiltrating lymphocyte |
| Extension set | Experimental | The number of TIL is decided by dose escalation experiment. Receives: Drug: Tumor infiltrating lymphocyte |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLT
To evaluate the tolerability and safty of autologous TILs in high-risk recurrent primary hepatocellular carcinoma.
Measured: 24 months
Progression-Free Survival
To evaluate the tolerability and safty of autologous TILs in high-risk recurrent primary hepatocellular carcinoma.
Measured: 24 months
Secondary outcomes (2)
Overall Survival Overall Survival
To evaluate the efficacy of autologous TILs in high-risk recurrent primary hepatocellular carcinoma.
Measured: 24 months
EQ-5D score
To evaluate the efficacy of autologous TILs in high-risk recurrent primary hepatocellular carcinoma.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2020
- Study start26 Aug 2020
- Primary completion31 Oct 2022 (estimated)
- Study completion31 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic CarcinomaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CAR-T (Shanghai) Cell Biotechnology Co., Ltd.
- Sponsor type
- Research network
- Collaborators
- Eastern Hepatobiliary Surgery Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04538313
- Sponsor's protocol ID
- KT-2020-TIL001
- Status last verified
- Aug 2020
- First submitted
- 26 Aug 2020
- Last updated
- 4 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Clinical Trials on Evaluating the Tolerance, Safety and Efficacy of Autologous TILs in High-risk Recurrent Primary Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT04538313
- Acronym / sponsor ID
- KT-2020-TIL001
- Conditions
- Hepatic Carcinoma
- Keywords
- TIL; HCC; clinical research
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- CAR-T (Shanghai) Cell Biotechnology Co., Ltd.Research network
- Collaborators
- Eastern Hepatobiliary Surgery Hospital
- Study start
- 26 Aug 2020 (actual)
- Primary completion
- 31 Oct 2022 (estimated)
- Study completion
- 31 Oct 2022 (estimated)
- First posted
- 4 Sep 2020 (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.
Early clinical trials on evaluating the tolerance, safety and efficacy of autologous TILs in high-risk recurrent primary hepatocellular carcinoma
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High dose group | Experimental | Drug: Tumor infiltrating lymphocyte10^10 TIL |
| Low dose group | Experimental | Drug: Tumor infiltrating lymphocyte10^9 TIL |
| Extension set | Experimental | Drug: Tumor infiltrating lymphocyteThe number of TIL is decided by dose escalation experiment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥18 years, gender unlimited;
- Patients diagnosis of primary hepatocellular carcinoma by histopathology and/or cytology;
- At the initial enrollment evaluation, patients were expected to accept radical resection of liver cancer and meet at least one of the following high-risk recurrence factors after surgery: ①There are 3 or more tumor lesions in the liver; ②The diameter of a single tumor lesion is >8cm; ③Existence macrovascular tumor thrombus; ④>5 MVI or MVI occurred in the distant paracancer tissues;
- Before enrollment (after radical resection of liver cancer), imaging evaluation was performed to ensure that the tumor was completely removed (clear margin);
- Must have at least 1 resectable lesion (diameter ≥2 cm);
Key exclusion criteria (17 listed)
- Primary hepatocellular carcinoma (HCC) has recurred in the past, or has other types of liver cancer at the same time (such as intrahepatic cholangiocarcinoma, mixed type of liver cancer);
- Have a history of high fever or severe infection within 2 weeks prior to pretreatment, or are expected to undergo systemic anti-infective therapy or systemic steroid therapy during this trial;
- Hepatic encephalopathy occurred within 2 weeks before pretreatment;
- Previous or screening with autoimmune liver disease;
- Screening with moderate or higher peritoneal effusion;
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 |
|---|---|---|
| Tumor infiltrating lymphocyteTumor infiltrating lymphocytes were isolated from tumor tissues from tumor biopsy or operation. These TILs were cultured in human IL-2 medium for 4 to 5 weeks. 10e9 to 10e10 TILs were yielded. The phenotype, function and sterile were detected before these TILs infused patients. | Drug | Extension set, High dose group, Low dose group |
Primary outcome
DLT
Time frame: 24 months
To evaluate the tolerability and safty of autologous TILs in high-risk recurrent primary hepatocellular carcinoma.
Progression-Free Survival
Time frame: 24 months
To evaluate the tolerability and safty of autologous TILs in high-risk recurrent primary hepatocellular carcinoma.
2 secondary outcomes
Overall Survival Overall Survival
Time frame: 24 months
EQ-5D score
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2020.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Tumor infiltrating lymphocyte in people with Hepatic Carcinoma, run by CAR-T (Shanghai) Cell Biotechnology Co., Ltd. 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 17 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 4 Sep 2020. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DLT (time frame: 24 months). The study lists 2 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 4 Sep 2020; AzTrials last refreshed its copy on 4 Nov 2026.