Liver CancerPhase 2NCT07685535
HAIC + DEB-TACE + Toripalimab + Lenvatinib for Unresectable Intrahepatic Cholangiocarcinoma
A Phase 2 study testing DEB-TACE, Toripalimab and Lenvatinib in people with Liver Cancer, run by Shanghai Zhongshan Hospital.
Trial summary
Purpose: This phase II clinical trial evaluates whether a combination of liver-directed local therapies (HAIC and DEB-TACE) with immunotherapy (toripalimab) and targeted therapy (lenvatinib) is safe and effective for patients with unresectable intrahepatic cholangiocarcinoma (a type of liver cancer that cannot be… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Liver Cancer
- What is being tested?
- DEB-TACE, Toripalimab and Lenvatinib
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2026to 31 Dec 2028
- Phase
- Phase 2
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntary participation and signed informed consent.
- Age 18 to 85 years.
- Pathologically confirmed intrahepatic cholangiocarcinoma.
- Imaging-confirmed unresectable locally advanced intrahepatic cholangiocarcinoma with measurable lesions (longest diameter ≥10 mm) per RECIST 1.1.
- No distant organ metastases (excluding lymph node metastases).
- Child-Pugh liver function grade A or good B (≤7 points).
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- ECOG performance status score 0-1 within 1 week before enrollment.
- Expected survival ≥12 weeks.
- No prior treatment with immune checkpoint inhibitors (including PD-1/PD-L1 antibodies and CTLA-4 inhibitors).
- Laboratory values within 7 days before enrollment meeting the following criteria:
- ANC ≥1.0×10⁹/L; platelets ≥50×10⁹/L; hemoglobin ≥90 g/L (without transfusion or G-CSF within 14 days before screening).
- Serum albumin ≥30 g/L; total bilirubin ≤1.5×ULN; ALT and AST ≤5×ULN; serum creatinine ≤1.5×ULN or CrCl >50 mL/min (Cockcroft-Gault formula).
- INR ≤2.3 or PT prolonged ≤6 seconds above normal range.
- Urine protein <2+ (if ≥2+, 24-hour quantification <1.0 g allowed).
Who cannot join
- Received other local treatments (excluding surgery) within 1 month before study entry. Prior TAE/TAI not allowed. Prior TACE >3 times not allowed.
- Prior systemic anti-tumor therapy (including targeted therapy, immunotherapy, chemotherapy).
- Concurrent or prior other malignancy within 5 years.
- Active autoimmune disease or history of autoimmune disease with potential relapse.
- Clinically symptomatic moderate-to-severe ascites requiring therapeutic paracentesis/drainage or Child-Pugh score >2; uncontrolled or moderate-to-large pleural/pericardial effusion.
- History of abdominal fistula, GI perforation, or intra-abdominal abscess within 6 months before study treatment.
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- History of thrombosis or embolic events (e.g., cerebrovascular accident including TIA, cerebral hemorrhage, cerebral infarction, pulmonary embolism) within 6 months before study treatment.
- Known inherited or acquired bleeding disorder or thrombotic tendency; currently or recently (within 10 days) receiving full-dose anticoagulants or thrombolytics for therapeutic purposes (prophylactic low-dose aspirin or LMWH allowed).
- Major vascular disease within 6 months before study treatment (e.g., aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis).
- Severe, non-healing, or dehisced wounds, active ulcers, or untreated fractures.
- Major surgery within 4 weeks before study treatment (excluding diagnostic) or anticipated need for major surgery during the study.
- History of intestinal obstruction or clinical signs/symptoms of GI obstruction within 6 months before study treatment.
- History of hepatic encephalopathy.
- Palliative radiotherapy for non-target lesions allowed only if completed ≥2 weeks before study treatment and AEs recovered to ≤CTCAE grade 1.
- Severe infection within 4 weeks before study treatment, including hospitalization for infection, bacteremia, or severe pneumonia; oral or IV therapeutic antibiotics within 2 weeks (prophylactic allowed).
- Congenital or acquired immunodeficiency (e.g., HIV infection).
- Palliative radiotherapy involving >5% of bone marrow area within 4 weeks for patients with bone metastases.
- Received live attenuated vaccine within 28 days before study treatment, or expected to receive such vaccine during toripalimab treatment or within 60 days after last dose.
- Received other investigational drugs within 28 days before study treatment.
- Other factors judged by the investigator that may affect study results or cause premature termination, such as alcoholism, drug abuse, other serious diseases (including psychiatric) requiring concomitant treatment, severe laboratory abnormalities, family or social factors affecting patient safety.
About this study
Official title: Hepatic Arterial Infusion Chemotherapy (HAIC) Sequential Small-Sized Drug-Eluting Beads Transarterial Chemoembolization (DEB-TACE) Combined With Toripalimab and Lenvatinib for Unresectable Intrahepatic Cholangiocarcinoma: A Phase II Clinical Study
Purpose: This phase II clinical trial evaluates whether a combination of liver-directed local therapies (HAIC and DEB-TACE) with immunotherapy (toripalimab) and targeted therapy (lenvatinib) is safe and effective for patients with unresectable intrahepatic cholangiocarcinoma (a type of liver cancer that cannot be removed by surgery).
Participants: Adults aged 18-85 years with pathologically confirmed unresectable intrahepatic cholangiocarcinoma, no prior immune checkpoint inhibitor therapy, and adequate organ function.
Read more
Study details include:
Study Duration: Up to 24 months per participant
Treatment Duration: Up to 6 cycles (each cycle is 21 days) of combination therapy, followed by maintenance therapy with toripalimab and lenvatinib until disease progression or unacceptable toxicity
Visit Frequency: Every 3 weeks during the treatment phase; tumor imaging assessments every 6-8 weeks
Primary endpoints: Objective response rate (ORR), progression-free survival (PFS), and overall survival (OS). Safety will be assessed by monitoring adverse events graded according to NCI-CTCAE v5.0.
Toripalimab and lenvatinib are not available through an expanded access program.
Read the detailed description
Background: Intrahepatic cholangiocarcinoma (ICC) is the second most common primary liver malignancy. Most patients are diagnosed at locally advanced or metastatic stages, precluding curative surgical resection. For unresectable ICC, conventional chemotherapy offers limited efficacy, with a 5-year survival rate below 10%. Emerging evidence suggests that combining locoregional therapies with immunotherapy and targeted therapy may improve outcomes.
Study Design: This is a prospective, single-arm, single-center, phase II exploratory clinical trial. Approximately 29 evaluable patients will be enrolled at Zhongshan Hospital, Fudan University.
Intervention: Participants will receive a comprehensive treatment regimen consisting of:
HAIC (Hepatic Arterial Infusion Chemotherapy): Oxaliplatin 85 mg/m² and gemcitabine (total 1000 mg/m², with a portion used for DEB-TACE loading) administered via hepatic artery infusion over ≥2 hours on Day 1 of each 21-day cycle, for up to 6 cycles.
DEB-TACE (Drug-Eluting Beads Transarterial Chemoembolization): Small-sized (40-90 μm) drug-eluting beads loaded with gemcitabine, performed on Day 1 of each cycle as needed (required in Cycle 1, thereafter based on tumor vascularity and imaging assessment).
Toripalimab: 200 mg intravenous infusion on Day 1 of each 21-day cycle.
Lenvatinib: Oral daily dosing (8 mg/day for body weight <60 kg; 12 mg/day for body weight ≥60 kg), continued throughout the study.
After completion of up to 6 cycles, patients without disease progression will enter a maintenance phase receiving toripalimab plus lenvatinib until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to terminate.
Efficacy Assessments: Tumor response will be evaluated by investigators using RECIST 1.1 and mRECIST criteria every 6-8 weeks. Primary efficacy endpoints include objective response rate (ORR), progression-free survival (PFS), and overall survival (OS).
Safety Monitoring: Adverse events will be monitored throughout the study and graded according to NCI-CTCAE v5.0. Safety visits will be conducted before each TACE procedure.
Statistical Considerations: The primary analysis will be descriptive. Sample size (approximately 29 patients) was calculated using a single-stage exact design based on an expected ORR of 40% versus a null rate of 15%, with α=0.05 and power=90%. Survival outcomes will be analyzed using Kaplan-Meier methods.
- Conditions
- Liver Cancer
- Being tested
- DEB-TACE, Toripalimab, Lenvatinib, Gemcitabine, Oxaliplatin
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DEB-TACEDevice
Small-sized (40-90 μm) drug-eluting beads loaded with gemcitabine, administered via transarterial chemoembolization into the hepatic artery to occlude tumor blood vessels and deliver localized chemotherapy. Performed on Day 1 of each 21-day cycle as needed (required in Cycle 1, thereafter based on tumor vascularity and imaging assessment).
ToripalimabDrug
200 mg administered as an intravenous infusion on Day 1 of each 21-day cycle. Toripalimab is a humanized anti-PD-1 monoclonal antibody that blocks PD-1/PD-L1 interaction, restoring T-cell anti-tumor immune activity.
LenvatinibDrug
Oral daily dosing: 8 mg/day for body weight <60 kg; 12 mg/day for body weight ≥60 kg. Lenvatinib is a multi-target tyrosine kinase inhibitor that inhibits VEGFR1-3, FGFR1-4, PDGFRα, KIT, and RET, thereby reducing tumor angiogenesis and suppressing tumor cell proliferation.
GemcitabineDrug
Total dose 1000 mg/m² administered via hepatic artery infusion (HAIC) on Day 1 of each 21-day cycle, for up to 6 cycles. A portion of the dose is used for DEB-TACE drug loading; the remainder is administered via HAIC. Gemcitabine is a pyrimidine nucleoside analog that inhibits DNA synthesis and induces tumor cell apoptosis.
OxaliplatinDrug
85 mg/m² administered via hepatic artery infusion (HAIC) on Day 1 of each 21-day cycle, for up to 6 cycles. Oxaliplatin is a third-generation platinum-based chemotherapeutic agent that forms DNA crosslinks, blocking DNA replication and transcription, and inducing tumor cell apoptosis.
| Study group | Role | What they receive |
|---|---|---|
| HAIC + DEB-TACE + Toripalimab + Lenvatinib | Experimental | Participants receive a combination regimen consisting of:
HAIC (Hepatic Arterial Infusion Chemotherapy): Oxaliplatin 85 mg/m² and gemcitabine (total 1000 mg/m², with a portion used for DEB-TACE loading) administered via hepatic artery infusion on Day 1 of each 21-day cycle, for up to 6 cycles.
DEB-TACE (Drug-Eluting Beads Transarterial Chemoembolization): Small-sized (40-90 μm) drug-eluting beads loaded with gemcitabine, performed on Day 1 of each cycle as needed (required in Cycle 1, thereafter based on tumor vascularity and imaging assessment).
Toripalimab: 200 mg intravenous infusion on Day 1 of each 21-day cycle.
Lenvatinib: Oral daily dosing (8 mg/day for body weight <60 kg; 12 mg/day for body weight ≥60 kg), continued throughout the study.
After completion of up to 6 cycles, patients without disease progression enter a maintenance phase receiving toripalimab plus lenvatinib until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to t Receives: Device: DEB-TACE; Drug: Toripalimab; Drug: Lenvatinib; Drug: Gemcitabine; Drug: Oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Proportion of participants achieving a confirmed complete response (CR) or partial response (PR) according to RECIST 1.1 and mRECIST criteria, assessed by the investigator. This is the primary efficacy endpoint used for sample size calculation.
Measured: From the start of treatment until disease progression, up to 24 months
Progression-Free Survival (PFS)
Time from enrollment to first documented disease progression per RECIST 1.1 and mRECIST criteria, or death from any cause, whichever occurs first.
Measured: From enrollment until disease progression or death, assessed up to 24 months
Overall Survival (OS)
Time from enrollment to death from any cause.
Measured: From enrollment until death, assessed up to 24 months
Secondary outcomes (3)
Disease Control Rate (DCR)
Proportion of participants achieving a confirmed complete response (CR), partial response (PR), or stable disease (SD) according to RECIST 1.1 and mRECIST criteria, assessed by the investigator.
Measured: From the start of treatment until disease progression, up to 24 months
Duration of Response (DoR)
Time from first documented response (CR or PR) to first documented disease progression per RECIST 1.1 and mRECIST criteria, or death from any cause, whichever occurs first.
Measured: From first response until disease progression or death, assessed up to 24 months
Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and laboratory abnormalities. Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0.
Measured: From the time of informed consent until 30 days after the last dose of study treatment, or until resolution/return to baseline, assessed up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start30 Jun 2026 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan 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
- Model description
- This is a single-arm, open-label study in which all participants will receive the same combination treatment regimen consisting of HAIC, DEB-TACE, toripalimab, and lenvatinib. No comparator or control group is included.
- Masking
- None (open label)
- Enrolment
- 29 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07685535
- Sponsor's protocol ID
- MATCH-002
- Status last verified
- Jun 2026
- First submitted
- 28 Jun 2026
- Last updated
- 6 Jul 2026
- 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 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatic Arterial Infusion Chemotherapy (HAIC) Sequential Small-Sized Drug-Eluting Beads Transarterial Chemoembolization (DEB-TACE) Combined With Toripalimab and Lenvatinib for Unresectable Intrahepatic Cholangiocarcinoma: A Phase II Clinical Study
- ClinicalTrials.gov ID
- NCT07685535
- Acronym / sponsor ID
- MATCH-002
- Conditions
- Liver Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 30 Jun 2026 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 6 Jul 2026 (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.
Purpose: This phase II clinical trial evaluates whether a combination of liver-directed local therapies (HAIC and DEB-TACE) with immunotherapy (toripalimab) and targeted therapy (lenvatinib) is safe and effective for patients with unresectable intrahepatic cholangiocarcinoma (a type of liver cancer that cannot be removed by surgery).
Participants: Adults aged 18-85 years with pathologically confirmed unresectable intrahepatic cholangiocarcinoma, no prior immune checkpoint inhibitor therapy, and adequate organ function.
Study details include:
Study Duration: Up to 24 months per participant
Treatment Duration: Up to 6 cycles (each cycle is 21 days) of combination therapy, followed by maintenance therapy with toripalimab and lenvatinib until disease progression or unacceptable toxicity
Visit Frequency: Every 3 weeks during the treatment phase; tumor imaging assessments every 6-8 weeks
Primary endpoints: Objective response rate (ORR), progression-free survival (PFS), and overall survival (OS). Safety will be assessed by monitoring adverse events graded according to NCI-CTCAE v5.0.
Toripalimab and lenvatinib are not available through an expanded access program.
Detailed description
Background: Intrahepatic cholangiocarcinoma (ICC) is the second most common primary liver malignancy. Most patients are diagnosed at locally advanced or metastatic stages, precluding curative surgical resection. For unresectable ICC, conventional chemotherapy offers limited efficacy, with a 5-year survival rate below 10%. Emerging evidence suggests that combining locoregional therapies with immunotherapy and targeted therapy may improve outcomes.
Study Design: This is a prospective, single-arm, single-center, phase II exploratory clinical trial. Approximately 29 evaluable patients will be enrolled at Zhongshan Hospital, Fudan University.
Intervention: Participants will receive a comprehensive treatment regimen consisting of:
HAIC (Hepatic Arterial Infusion Chemotherapy): Oxaliplatin 85 mg/m² and gemcitabine (total 1000 mg/m², with a portion used for DEB-TACE loading) administered via hepatic artery infusion over ≥2 hours on Day 1 of each 21-day cycle, for up to 6 cycles.
DEB-TACE (Drug-Eluting Beads Transarterial Chemoembolization): Small-sized (40-90 μm) drug-eluting beads loaded with gemcitabine, performed on Day 1 of each cycle as needed (required in Cycle 1, thereafter based on tumor vascularity and imaging assessment).
Toripalimab: 200 mg intravenous infusion on Day 1 of each 21-day cycle.
Lenvatinib: Oral daily dosing (8 mg/day for body weight <60 kg; 12 mg/day for body weight ≥60 kg), continued throughout the study.
After completion of up to 6 cycles, patients without disease progression will enter a maintenance phase receiving toripalimab plus lenvatinib until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to terminate.
Efficacy Assessments: Tumor response will be evaluated by investigators using RECIST 1.1 and mRECIST criteria every 6-8 weeks. Primary efficacy endpoints include objective response rate (ORR), progression-free survival (PFS), and overall survival (OS).
Safety Monitoring: Adverse events will be monitored throughout the study and graded according to NCI-CTCAE v5.0. Safety visits will be conducted before each TACE procedure.
Statistical Considerations: The primary analysis will be descriptive. Sample size (approximately 29 patients) was calculated using a single-stage exact design based on an expected ORR of 40% versus a null rate of 15%, with α=0.05 and power=90%. Survival outcomes will be analyzed using Kaplan-Meier methods.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-arm, open-label study in which all participants will receive the same combination treatment regimen consisting of HAIC, DEB-TACE, toripalimab, and lenvatinib. No comparator or control group is included.
| Arm | Type | Receives |
|---|---|---|
| HAIC + DEB-TACE + Toripalimab + Lenvatinib | Experimental | Device: DEB-TACE, Drug: Toripalimab, Drug: Lenvatinib, Drug: Gemcitabine, Drug: OxaliplatinParticipants receive a combination regimen consisting of: HAIC (Hepatic Arterial Infusion Chemotherapy): Oxaliplatin 85 mg/m² and gemcitabine (total 1000 mg/m², with a portion used for DEB-TACE loading) administered via hepatic artery infusion on Day 1 of each 21-day cycle, for up to 6 cycles. DEB-TACE (Drug-Eluting Beads Transarterial Chemoembolization): Small-sized (40-90 μm) drug-eluting beads loaded with gemcitabine, performed on Day 1 of each cycle as needed (required in Cycle 1, thereafter based on tumor vascularity and imaging assessment). Toripalimab: 200 mg intravenous infusion on Day 1 of each 21-day cycle. Lenvatinib: Oral daily dosing (8 mg/day for body weight <60 kg; 12 mg/day for body weight ≥60 kg), continued throughout the study. After completion of up to 6 cycles, patients without disease progression enter a maintenance phase receiving toripalimab plus lenvatinib until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to t |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Voluntary participation and signed informed consent.
- Age 18 to 85 years.
- Pathologically confirmed intrahepatic cholangiocarcinoma.
- Imaging-confirmed unresectable locally advanced intrahepatic cholangiocarcinoma with measurable lesions (longest diameter ≥10 mm) per RECIST 1.1.
- No distant organ metastases (excluding lymph node metastases).
Key exclusion criteria (20 listed)
- Received other local treatments (excluding surgery) within 1 month before study entry. Prior TAE/TAI not allowed. Prior TACE >3 times not allowed.
- Prior systemic anti-tumor therapy (including targeted therapy, immunotherapy, chemotherapy).
- Concurrent or prior other malignancy within 5 years.
- Active autoimmune disease or history of autoimmune disease with potential relapse.
- Clinically symptomatic moderate-to-severe ascites requiring therapeutic paracentesis/drainage or Child-Pugh score >2; uncontrolled or moderate-to-large pleural/pericardial 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 |
|---|---|---|
| DEB-TACESmall-sized (40-90 μm) drug-eluting beads loaded with gemcitabine, administered via transarterial chemoembolization into the hepatic artery to occlude tumor blood vessels and deliver localized chemotherapy. Performed on Day 1 of each 21-day cycle as needed (required in Cycle 1, thereafter based on tumor vascularity and imaging assessment). | Device | HAIC + DEB-TACE + Toripalimab + Lenvatinib |
| Toripalimab200 mg administered as an intravenous infusion on Day 1 of each 21-day cycle. Toripalimab is a humanized anti-PD-1 monoclonal antibody that blocks PD-1/PD-L1 interaction, restoring T-cell anti-tumor immune activity. | Drug | HAIC + DEB-TACE + Toripalimab + Lenvatinib |
| LenvatinibOral daily dosing: 8 mg/day for body weight <60 kg; 12 mg/day for body weight ≥60 kg. Lenvatinib is a multi-target tyrosine kinase inhibitor that inhibits VEGFR1-3, FGFR1-4, PDGFRα, KIT, and RET, thereby reducing tumor angiogenesis and suppressing tumor cell proliferation. | Drug | HAIC + DEB-TACE + Toripalimab + Lenvatinib |
| GemcitabineTotal dose 1000 mg/m² administered via hepatic artery infusion (HAIC) on Day 1 of each 21-day cycle, for up to 6 cycles. A portion of the dose is used for DEB-TACE drug loading; the remainder is administered via HAIC. Gemcitabine is a pyrimidine nucleoside analog that inhibits DNA synthesis and induces tumor cell apoptosis. | Drug | HAIC + DEB-TACE + Toripalimab + Lenvatinib |
| Oxaliplatin85 mg/m² administered via hepatic artery infusion (HAIC) on Day 1 of each 21-day cycle, for up to 6 cycles. Oxaliplatin is a third-generation platinum-based chemotherapeutic agent that forms DNA crosslinks, blocking DNA replication and transcription, and inducing tumor cell apoptosis. | Drug | HAIC + DEB-TACE + Toripalimab + Lenvatinib |
Primary outcome
Objective Response Rate (ORR)
Time frame: From the start of treatment until disease progression, up to 24 months
Proportion of participants achieving a confirmed complete response (CR) or partial response (PR) according to RECIST 1.1 and mRECIST criteria, assessed by the investigator. This is the primary efficacy endpoint used for sample size calculation.
Progression-Free Survival (PFS)
Time frame: From enrollment until disease progression or death, assessed up to 24 months
Time from enrollment to first documented disease progression per RECIST 1.1 and mRECIST criteria, or death from any cause, whichever occurs first.
Overall Survival (OS)
Time frame: From enrollment until death, assessed up to 24 months
Time from enrollment to death from any cause.
3 secondary outcomes
Disease Control Rate (DCR)
Time frame: From the start of treatment until disease progression, up to 24 months
Duration of Response (DoR)
Time frame: From first response until disease progression or death, assessed up to 24 months
Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From the time of informed consent until 30 days after the last dose of study treatment, or until resolution/return to baseline, assessed up to 24 months
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 6 Jul 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DEB-TACE, Toripalimab and Lenvatinib in people with Liver Cancer, run by Shanghai Zhongshan Hospital.
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 20 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: opening soon, as of the sponsor's last update on 6 Jul 2026. 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.
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?
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?
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?
Objective Response Rate (ORR) (time frame: From the start of treatment until disease progression, up to 24 months). 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 6 Jul 2026.