Hepatocellular CarcinomaPhase 2HAICPD1-HCCNCT03869034
HAIC Combined with PD-1 Inhibitor in Potentially Resectable Locally Advanced HCC
A Phase 2 study testing HAIC+PD1 and HAIC in people with Hepatocellular Carcinoma, run by Sun Yat-sen University at 1 site in China.
Trial summary
Hepatocellular carcinoma patients are mostly diagnosed at locally advanced stage. Nowadays, hepatic artery interventional therapy and/or systemic therapy are the main treatments options for these patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- HAIC+PD1 and HAIC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 25 Mar 2019to 31 Dec 2025
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 years and 70 years.
- Hepatocellular carcinoma: patients need to be diagnosed as hepatocellular carcinoma (HCC) histologically before treatment.
- Never received any anti-cancer treatment in the past.
- potentially resectable Locally advanced HCC: with at least one measurable lesion (RECIST 1.1), and tumor(s) confined to the left or right hemi-liver, with macroscopic invasion to branch of the portal vein and/or hepatic vein.
- No extrahepatic metastases.
- No contraindications for the treatment of HAIC and PD-1 inhibitors.
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- KPS≥90.
- Liver function: Child-Pugh class A.
- The expected survival of the patient is more than 6 months.
- Adequate hematological and organ function.
- The following conditions are met:
- Platelet≥75×10^9/L; White blood cell≥3.0×10^9/L; Hemoglobin≥90 g/L; Serum creatinine≤1.5 × upper limit of normal (ULN); PT≤3 second extension; total bilirubin ≤1.5 x ULN； AST and ALT ≤2.5 x ULN.
- Agree to accept postoperative follow-up required by the design of this study.
- Patients must have the ability to understand and voluntarily sign the informed consent, and must sign an informed consent before starting any specific procedure for the study.
Who cannot join
- In combined with severe heart, lung, kidney or other important organ dysfunction, or combined with serious infection or other serious associated diseases, that cannot tolerate treatment (> CTCAE Version 4.03 adverse events of grade 2).
- With uncontrolled hepatitis B (HBV-DNA>2000 IU/ml and elevated ALT).
- Multi-nodules hepatocellular carcinoma beyond hemi-hepatic range.
- Patients with tumor thrombus reaches or exceeds the portal vein.
- History of other malignancies.
- History of allergic reactions to related drugs.
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- History of organ transplantation.
- Pregnant women, nursing mothers.
- Patients have other factors that may interfere with patient enrollment and assessment results.
- Refuse follow-up as required by this study protocol and refuse to sign informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hepatic Arterial Infusion Chemotherapy Combined with PD-1 Inhibitor in Treating Potentially Resectable Locally Advanced Hepatocellular Carcinoma: a Prospective, Phase II Clinical Study
Hepatocellular carcinoma patients are mostly diagnosed at locally advanced stage. Nowadays, hepatic artery interventional therapy and/or systemic therapy are the main treatments options for these patients. Our previous study showed that compared to than conventional transcatheter arterial chemoembolization (TACE), hepatic arterial infusion chemotherapy (HAIC) has better objective response, better safety profile, and increased resection rates. The PD-1 inhibitors emerged in recent years have shown good momentum in the treatment of hepatocellular carcinoma. The single-drug treatment on advanced hepatocellular carcinoma has a tumor response rate of 17%, the disease control rate exceeds 60%, and the overall survival time exceeds 12 months. And it has good tolerance and less adverse events. In studies of other cancer, combined with traditional chemotherapy can further improve the efficacy of PD-1 inhibitors. Our study is a prospective phase II clinical study for patients with potentially resectable locally advanced hepatocellular carcinoma (tumor confined to the liver with invasion to branches of the portal vein or hepatic vein). Progressive survival (PFS) is the primary end point of study. The OS and overall survival rate, RFS, ORR, DCR, conversion rate, pathological response, and safety are the secondary endpoints. The efficacy and safety of HAIC combined with PD-1 inhibitor in the treatment of potentially resectable locally advanced hepatocellular carcinoma will be discussed.
Read the detailed description
Sintilimab (IBI308) is a recombinant human IgG4 PD-1 monoclonal antibody. It has been proved in many preclinical and in vitro trials that the effect of blocking PD-1 pathway with Sintilimab on. The results of preclinical pharmacodynamics, animal pharmacokinetics and toxicology all indicated that Sintilimab has clear targets, reliable cell lines and drug stability. It has considerable characteristics and has shown good activity in various preclinical studies.
Hepatocellular carcinoma patients are mostly diagnosed in locally advanced stage, and hepatic artery interventional therapy and/or systemic therapy are the main treatments options for these patients. In recent years, some researchers have reported that chemotherapy plays a critical role in transcatheter arterial intervention (Shi et al. JNCI, 2012, 105: 59). Compared with transcatheter arterial chemoembolization (TACE), hepatic arterial infusion chemotherapy (HAIC) provides a more stable and long-lasting local control rate, which promised better outcomes. However, the effectiveness of HAIC varies greatly depending on the chemotherapy drug used, with an efficiency ranging from 7-81% and OS ranging from 6-15.9 months.
The single-drug treatment of PD-1 inhibitor in advanced hepatocellular carcinoma has a tumor response rate of 17%, the disease control rate exceeds 60%, and the overall survival time exceeds 12 months. And it has good tolerance and less adverse events. In studies in other cancers, combined with traditional chemotherapy can further improve the efficacy of PD-1 inhibitors.
Our study is a prospective phase II clinical study for patients with potentially resectable locally advanced hepatocellular carcinoma (tumor confined to the liver with invasion to branches of the portal vein or hepatic vein). Progressive survival (PFS) based on RECIST 1.1 is the primary end point of the present study. The OS and overall survival rate, RFS, ORR, DCR, conversion rate, pathological response, and safety are the secondary endpoints. The exploratory endpoints included the research on biomarkers. The efficacy and safety of HAIC combined with PD-1 inhibitor in the treatment of potentially resectable locally advanced hepatocellular carcinoma will be discussed.
Radiological assessments are performed every two cycles over the course of treatment, then every 3 months within the first two years following the completion of treatment and every 6 months thereafter, until PD were recorded. All subjects are followed until death or lost to follow up. The recurrence, metastasis sites, detection methods, adjuvant treatment and accurate survival time were recorded in detail.
Due to the lack of historical data and expected effect size for this population, the sample size of this pilot study is arbitrarily set at 40, including two intervention arms. Arm A will included 30 patients who receive HAIC combined with sintilimab. Arm B will included 10 patients who receive only HAIC. The patients are assigned to any group according to their willing.
The Kaplan-Meier method was used to estimate progression-free survival and overall survival; the Log-rank method was used for single factor analysis; the Cox model was analyzed by multivariate analysis. All the statistical tests were two-sided, and P < 0.05 was considered statistically significant.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- HAIC+PD1, HAIC
- Keywords
- Hepatic arterial Infusion Chemotherapy, PD-1 Inhibitor, Hepatocellular Carcinoma
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HAIC+PD1Combination product
Also called Sintilimab (IBI308), FOLFOX-HAIC
Sintilimab ( 200mg Q3W iv D1)+FOLFOX-HAIC（oxaliplatin, 130 mg/m2 and leucovorin, 200 mg/m2, and fluorouracil, 400 mg/m2, bolus and 2400 mg/m2 over 46 hours Q3W D2 D3), maximally 8 cycles Multi-disciplinary consultation was organized to decide the chance of surgery and subsequent treatment per 2 treatment cycles. Patients who achieved partial response (PR) or minor response (MR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and were assessed as eligible for R0 resection go on to undergo surgical resection. After recovery from operation , sintilimab monotherapy was given per three weeks for maximally 16 doses. Patients who were ineligible for resection would continue to receive the combination therapy.
HAICDrug
Also called FOLFOX-HAIC
FOLFOX-HAIC: oxaliplatin, 130 mg/m2 and leucovorin, 200 mg/m2, and fluorouracil, 400 mg/m2, bolus and 2400 mg/m2 over 46 hours Q3W D2 D3, for maximally 8 cycles, and the safety parameters are reviewed before the start of each course of HAIC treatment. Patients who achieve partial response (PR) or minor response (MR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and are assessed as eligible for R0 resection go on to undergo surgical resection. No other anti-tumor therapies are allowed before PD or postoperative relapse is confirmed.
| Study group | Role | What they receive |
|---|---|---|
| A, Combination group (HAIC+PD-1) | Experimental | HAIC+PD-1 Receives: Combination Product: HAIC+PD1 |
| B, HAIC group (HAIC only) | Experimental | HAIC Receives: Drug: HAIC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS) assessed by RECIST 1.1
The duration from treatment initiation to disease progression or death from any cause in patients who did not undergo surgery, or to the date of postoperative relapse or death from any cause in patients who had received surgery, whichever occurs first. The baseline of the tumor before the initial treatment was used as a reference, and the assessments are performed according to the RECIST 1.1 criteria based on the imaging test (enhanced CT or MRI).
Measured: From date of the first treatment until the date of progression or death from any cause, whichever occurs first, assessed up to 96 months
Secondary outcomes (8)
Overall survival (OS)
The time between the first HAIC +PD1 treatment and death from any cause.
Measured: From date of the first treatment until the date of death from any cause, assessed up to 96 months
1-, 2- and 3-year Overall Survival (OS) rate
The percentage of patients who were still alive at the 1-, 2-, and 3-year time point since the first cycle of treatment. The end point of observation is death due to tumor.
Measured: From date of the first treatment until the date of death from any cause, assessed up to 96 months
Safety: the percentage of participants with treatment-related adverse events as assessed by CTCAE v4.03
adverse events will be assessed and reported according to NCI CTC AE v4.03.
Measured: From date of the first treamtment until 100 days after the last treatment.
Pathological Response: pathological complete response (pCR) and major pathological response (MPR: >90% of tumor necrosis)
According to post-operative pathology, the proportion of tumor necrosis, viable. tumor cells, and tumor infiltrating lymphocytes indicated by surgical resected specimens.
Measured: Through study completion, an average of 1 year.
Objective Response Rate (ORR) assessed by RECIST 1.1
The proportion of complete response or partial response as optimal response among all treated patients.
Measured: Through study completion, an average of 3 year.
Disease Control Rate (DCR)
The proportion of complete response, partial response or stable disease as optimal response assessed by RECIST 1.1 among all treated patients.
Measured: Through study completion, an average of 3 year.
Conversion rate
The proportion of patients who received surgical resection among all treated patients.
Measured: Through study completion, an average of 1 year.
Recurrence-free survival (RFS)
The time between surgery and first recurrence/metastasis after resection or death from any cause, whichever occurs first.
Measured: From date of the surgery until the date of first recurrence/metastasis after resection or death from any cause, assessed up to 96 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2019
- Study start25 Mar 2019
- Primary completion20 Jul 2020
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Patients enroll in this study will receive hepatic arterial infusion chemotherapy with FOLFOX regimen (FOLFOX-HAIC), or combined with Sintilimab PD-1 inhibitor.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Innovent Biologics, Inc.
- Responsible party
- Principal investigator, XU li, Sun Yat-sen University
- Investigators
- Min-shan Chen, MD, PhD, Principal investigator, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03869034
- Sponsor's protocol ID
- HAICPD1-HCC
- Acronym
- HAICPD1-HCC
- Status last verified
- Nov 2024
- First submitted
- 2 Mar 2019
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data that support the findings of this study will be openly available in Research Data Deposit at https://www.researchdata.org.cn/default.aspx, after publication.
Publications
Lyu N, Kong Y, Mu L, Lin Y, Li J, Liu Y, Zhang Z, Zheng L, Deng H, Li S, Xie Q, Guo R, Shi M, Xu L, Cai X, Wu P, Zhao M. Hepatic arterial infusion of oxaliplatin plus fluorouracil/leucovorin vs. sorafenib for advanced hepatocellular carcinoma. J Hepatol. 2018 Jul;69(1):60-69. doi: 10.1016/j.jhep.2018.02.008. Epub 2018 Feb 20.
PubMed 29471013Lyu N, Lin Y, Kong Y, Zhang Z, Liu L, Zheng L, Mu L, Wang J, Li X, Pan T, Xie Q, Liu Y, Lin A, Wu P, Zhao M. FOXAI: a phase II trial evaluating the efficacy and safety of hepatic arterial infusion of oxaliplatin plus fluorouracil/leucovorin for advanced hepatocellular carcinoma. Gut. 2018 Feb;67(2):395-396. doi: 10.1136/gutjnl-2017-314138. Epub 2017 Jun 7. No abstract available.
PubMed 28592441He MK, Le Y, Li QJ, Yu ZS, Li SH, Wei W, Guo RP, Shi M. Hepatic artery infusion chemotherapy using mFOLFOX versus transarterial chemoembolization for massive unresectable hepatocellular carcinoma: a prospective non-randomized study. Chin J Cancer. 2017 Oct 23;36(1):83. doi: 10.1186/s40880-017-0251-2.
PubMed 29061175Pan Y, Wang X, Peng C, Zhao J, Lu S, Zhang C, Wang J, Fu Y, Zhou Z, Chen M, Zhang Y, Xu L. Hepatic arterial infusion chemotherapy plus sintilimab as conversion therapy for locally advanced hepatocellular carcinoma: a single-center phase II trial. Int J Surg. 2026 Jan 13;112(4):9753-60. doi: 10.1097/JS9.0000000000004692. Online ahead of print.
PubMed 41537370
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatic Arterial Infusion Chemotherapy Combined with PD-1 Inhibitor in Treating Potentially Resectable Locally Advanced Hepatocellular Carcinoma: a Prospective, Phase II Clinical Study
- ClinicalTrials.gov ID
- NCT03869034
- Acronym / sponsor ID
- HAICPD1-HCC / HAICPD1-HCC
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatic arterial Infusion Chemotherapy, PD-1 Inhibitor, Hepatocellular Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Innovent Biologics, Inc.
- Study start
- 25 Mar 2019 (actual)
- Primary completion
- 20 Jul 2020 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 11 Mar 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.
Hepatocellular carcinoma patients are mostly diagnosed at locally advanced stage. Nowadays, hepatic artery interventional therapy and/or systemic therapy are the main treatments options for these patients. Our previous study showed that compared to than conventional transcatheter arterial chemoembolization (TACE), hepatic arterial infusion chemotherapy (HAIC) has better objective response, better safety profile, and increased resection rates. The PD-1 inhibitors emerged in recent years have shown good momentum in the treatment of hepatocellular carcinoma. The single-drug treatment on advanced hepatocellular carcinoma has a tumor response rate of 17%, the disease control rate exceeds 60%, and the overall survival time exceeds 12 months. And it has good tolerance and less adverse events. In studies of other cancer, combined with traditional chemotherapy can further improve the efficacy of PD-1 inhibitors. Our study is a prospective phase II clinical study for patients with potentially resectable locally advanced hepatocellular carcinoma (tumor confined to the liver with invasion to branches of the portal vein or hepatic vein). Progressive survival (PFS) is the primary end point of study. The OS and overall survival rate, RFS, ORR, DCR, conversion rate, pathological response, and safety are the secondary endpoints. The efficacy and safety of HAIC combined with PD-1 inhibitor in the treatment of potentially resectable locally advanced hepatocellular carcinoma will be discussed.
Detailed description
Sintilimab (IBI308) is a recombinant human IgG4 PD-1 monoclonal antibody. It has been proved in many preclinical and in vitro trials that the effect of blocking PD-1 pathway with Sintilimab on. The results of preclinical pharmacodynamics, animal pharmacokinetics and toxicology all indicated that Sintilimab has clear targets, reliable cell lines and drug stability. It has considerable characteristics and has shown good activity in various preclinical studies.
Hepatocellular carcinoma patients are mostly diagnosed in locally advanced stage, and hepatic artery interventional therapy and/or systemic therapy are the main treatments options for these patients. In recent years, some researchers have reported that chemotherapy plays a critical role in transcatheter arterial intervention (Shi et al. JNCI, 2012, 105: 59). Compared with transcatheter arterial chemoembolization (TACE), hepatic arterial infusion chemotherapy (HAIC) provides a more stable and long-lasting local control rate, which promised better outcomes. However, the effectiveness of HAIC varies greatly depending on the chemotherapy drug used, with an efficiency ranging from 7-81% and OS ranging from 6-15.9 months.
The single-drug treatment of PD-1 inhibitor in advanced hepatocellular carcinoma has a tumor response rate of 17%, the disease control rate exceeds 60%, and the overall survival time exceeds 12 months. And it has good tolerance and less adverse events. In studies in other cancers, combined with traditional chemotherapy can further improve the efficacy of PD-1 inhibitors.
Our study is a prospective phase II clinical study for patients with potentially resectable locally advanced hepatocellular carcinoma (tumor confined to the liver with invasion to branches of the portal vein or hepatic vein). Progressive survival (PFS) based on RECIST 1.1 is the primary end point of the present study. The OS and overall survival rate, RFS, ORR, DCR, conversion rate, pathological response, and safety are the secondary endpoints. The exploratory endpoints included the research on biomarkers. The efficacy and safety of HAIC combined with PD-1 inhibitor in the treatment of potentially resectable locally advanced hepatocellular carcinoma will be discussed.
Radiological assessments are performed every two cycles over the course of treatment, then every 3 months within the first two years following the completion of treatment and every 6 months thereafter, until PD were recorded. All subjects are followed until death or lost to follow up. The recurrence, metastasis sites, detection methods, adjuvant treatment and accurate survival time were recorded in detail.
Due to the lack of historical data and expected effect size for this population, the sample size of this pilot study is arbitrarily set at 40, including two intervention arms. Arm A will included 30 patients who receive HAIC combined with sintilimab. Arm B will included 10 patients who receive only HAIC. The patients are assigned to any group according to their willing.
The Kaplan-Meier method was used to estimate progression-free survival and overall survival; the Log-rank method was used for single factor analysis; the Cox model was analyzed by multivariate analysis. All the statistical tests were two-sided, and P < 0.05 was considered statistically significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients enroll in this study will receive hepatic arterial infusion chemotherapy with FOLFOX regimen (FOLFOX-HAIC), or combined with Sintilimab PD-1 inhibitor.
| Arm | Type | Receives |
|---|---|---|
| A, Combination group (HAIC+PD-1) | Experimental | Combination Product: HAIC+PD1HAIC+PD-1 |
| B, HAIC group (HAIC only) | Experimental | Drug: HAICHAIC |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Age between 18 years and 70 years.
- Hepatocellular carcinoma: patients need to be diagnosed as hepatocellular carcinoma (HCC) histologically before treatment.
- Never received any anti-cancer treatment in the past.
- potentially resectable Locally advanced HCC: with at least one measurable lesion (RECIST 1.1), and tumor(s) confined to the left or right hemi-liver, with macroscopic invasion to branch of the portal vein and/or hepatic vein.
- No extrahepatic metastases.
Key exclusion criteria (10 listed)
- In combined with severe heart, lung, kidney or other important organ dysfunction, or combined with serious infection or other serious associated diseases, that cannot tolerate treatment (> CTCAE Version 4.03 adverse events of grade 2).
- With uncontrolled hepatitis B (HBV-DNA>2000 IU/ml and elevated ALT).
- Multi-nodules hepatocellular carcinoma beyond hemi-hepatic range.
- Patients with tumor thrombus reaches or exceeds the portal vein.
- History of other malignancies.
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 |
|---|---|---|
| HAIC+PD1Also: Sintilimab (IBI308), FOLFOX-HAICSintilimab ( 200mg Q3W iv D1)+FOLFOX-HAIC（oxaliplatin, 130 mg/m2 and leucovorin, 200 mg/m2, and fluorouracil, 400 mg/m2, bolus and 2400 mg/m2 over 46 hours Q3W D2 D3), maximally 8 cycles Multi-disciplinary consultation was organized to decide the chance of surgery and subsequent treatment per 2 treatment cycles. Patients who achieved partial response (PR) or minor response (MR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and were assessed as eligible for R0 resection go on to undergo surgical resection. After recovery from operation , sintilimab monotherapy was given per three weeks for maximally 16 doses. Patients who were ineligible for resection would continue to receive the combination therapy. | Combination product | A, Combination group (HAIC+PD-1) |
| HAICAlso: FOLFOX-HAICFOLFOX-HAIC: oxaliplatin, 130 mg/m2 and leucovorin, 200 mg/m2, and fluorouracil, 400 mg/m2, bolus and 2400 mg/m2 over 46 hours Q3W D2 D3, for maximally 8 cycles, and the safety parameters are reviewed before the start of each course of HAIC treatment. Patients who achieve partial response (PR) or minor response (MR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and are assessed as eligible for R0 resection go on to undergo surgical resection. No other anti-tumor therapies are allowed before PD or postoperative relapse is confirmed. | Drug | B, HAIC group (HAIC only) |
Primary outcome
Progression Free Survival (PFS) assessed by RECIST 1.1
Time frame: From date of the first treatment until the date of progression or death from any cause, whichever occurs first, assessed up to 96 months
The duration from treatment initiation to disease progression or death from any cause in patients who did not undergo surgery, or to the date of postoperative relapse or death from any cause in patients who had received surgery, whichever occurs first. The baseline of the tumor before the initial treatment was used as a reference, and the assessments are performed according to the RECIST 1.1 criteria based on the imaging test (enhanced CT or MRI).
8 secondary outcomes
Overall survival (OS)
Time frame: From date of the first treatment until the date of death from any cause, assessed up to 96 months
1-, 2- and 3-year Overall Survival (OS) rate
Time frame: From date of the first treatment until the date of death from any cause, assessed up to 96 months
Safety: the percentage of participants with treatment-related adverse events as assessed by CTCAE v4.03
Time frame: From date of the first treamtment until 100 days after the last treatment.
Pathological Response: pathological complete response (pCR) and major pathological response (MPR: >90% of tumor necrosis)
Time frame: Through study completion, an average of 1 year.
Objective Response Rate (ORR) assessed by RECIST 1.1
Time frame: Through study completion, an average of 3 year.
Disease Control Rate (DCR)
Time frame: Through study completion, an average of 3 year.
Conversion rate
Time frame: Through study completion, an average of 1 year.
Recurrence-free survival (RFS)
Time frame: From date of the surgery until the date of first recurrence/metastasis after resection or death from any cause, assessed up to 96 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 3 Dec 2024.
- Background: PubMed 29471013Lyu N, Kong Y, Mu L, Lin Y, Li J, Liu Y, Zhang Z, Zheng L, Deng H, Li S, Xie Q, Guo R, Shi M, Xu L, Cai X, Wu P, Zhao M. Hepatic arterial infusion of oxaliplatin plus fluorouracil/leucovorin vs. sorafenib for advanced hepatocellular carcinoma. J Hepatol. 2018 Jul;69(1):60-69. doi: 10.1016/j.jhep.2018.02.008. Epub 2018 Feb 20.
- Background: PubMed 28592441Lyu N, Lin Y, Kong Y, Zhang Z, Liu L, Zheng L, Mu L, Wang J, Li X, Pan T, Xie Q, Liu Y, Lin A, Wu P, Zhao M. FOXAI: a phase II trial evaluating the efficacy and safety of hepatic arterial infusion of oxaliplatin plus fluorouracil/leucovorin for advanced hepatocellular carcinoma. Gut. 2018 Feb;67(2):395-396. doi: 10.1136/gutjnl-2017-314138. Epub 2017 Jun 7. No abstract available.
- Background: PubMed 29061175He MK, Le Y, Li QJ, Yu ZS, Li SH, Wei W, Guo RP, Shi M. Hepatic artery infusion chemotherapy using mFOLFOX versus transarterial chemoembolization for massive unresectable hepatocellular carcinoma: a prospective non-randomized study. Chin J Cancer. 2017 Oct 23;36(1):83. doi: 10.1186/s40880-017-0251-2.
- Derived from this study: PubMed 41537370Pan Y, Wang X, Peng C, Zhao J, Lu S, Zhang C, Wang J, Fu Y, Zhou Z, Chen M, Zhang Y, Xu L. Hepatic arterial infusion chemotherapy plus sintilimab as conversion therapy for locally advanced hepatocellular carcinoma: a single-center phase II trial. Int J Surg. 2026 Jan 13;112(4):9753-60. doi: 10.1097/JS9.0000000000004692. Online ahead of print.
- Individual participant dataSharing planned: Yes. The data that support the findings of this study will be openly available in Research Data Deposit at https://www.researchdata.org.cn/default.aspx, after publication.
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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.
Min-shan Chen, MD, PhD principal investigator
Sun Yat-Sen University Cancer Center
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 HAIC+PD1 and HAIC in people with Hepatocellular Carcinoma, run by Sun Yat-sen University 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 14 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 3 Dec 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?
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?
Progression Free Survival (PFS) assessed by RECIST 1.1 (time frame: From date of the first treatment until the date of progression or death from any cause, whichever occurs first, assessed up to 96 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03869034, which also lists 4 linked publications.
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 3 Dec 2024.