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Hepatocellular Carcinoma (HCC)Phase 1/2HAICINCT06741020

Hepatic Arterial Infusion Chemotherapy and Immunotherapy for Hepatocellular Carcinoma

A Phase 1/2 study testing Adebrelimab, Oxaliplatin, Fluorouracil,Leucovorin in people with Hepatocellular Carcinoma (HCC), run by Zhejiang Cancer Hospital at 2 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Dear Sir/Madam, We would like to invite you to participate in this clinical research, which has been approved by the Medical Ethics Committee of Zhejiang Cancer Hospital. This informed consent form provides you with detailed information to help you decide whether or not to participate in this study. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Hepatocellular Carcinoma (HCC)
What is being tested?
Adebrelimab, Oxaliplatin, Fluorouracil,Leucovorin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
2 sitesChina
Study dates
1 Mar 2025to 30 Dec 2026
Phase
Phase 1/2
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged between 18 and 75 years;
  • Preoperative pathological diagnosis or clinically diagnosed liver cancer meeting EASL/AASLD diagnostic criteria. No prior systemic chemotherapy, immunotherapy, targeted therapy, or other anti-tumor treatments for HCC;
  • Staging in BCLC Stage A or B, and beyond the Up-to-Seven criteria but deemed resectable (negative margins and remaining liver volume sufficient to meet body needs);
  • ECOG performance status score of 0 before the first medication in the study;
  • Liver function classified as Child-Pugh Class A and ICG retention rate at 15 minutes ≤ 10%;
  • Estimated survival time of at least 6 months;
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  • Organ function levels meet the requirements and are capable of tolerating surgery before the first medication in the study; Key organ function indicators must meet the following criteria: Hemoglobin ≥ 90 g/L, Neutrophil count ≥ 1.5 × 10⁹/L, Platelet count ≥ 100 × 10⁹/L; Aspartate or Alanine aminotransferase ≤ 5 times the upper limit of normal (ULN), Alkaline phosphatase ≤ 2.5 ULN, Serum albumin ≥ 30 g/L; Serum creatinine < 1.5 ULN; International Normalized Ratio (INR) ≤ 2 or Prothrombin Time (PT) exceeding the upper limit of normal ≤ 6 seconds; Serum creatinine ≤ 1.5 ULN, Creatinine clearance ≥ 60 mL/min.
  • Male and female participants with reproductive potential must agree to use effective contraception throughout the study period;
  • Sign a consent form agreeing to provide previously stored blood samples, tumor tissue specimens, or fresh biopsy tumor lesions.

Who cannot join

  • Pathological diagnosis of non-hepatocellular carcinoma;
  • Previous treatment for liver cancer-related chemotherapy, radiotherapy, radiofrequency ablation, interventional therapies and targeted therapy, immunotherapy, or surgical procedures (excluding prior non-tumor-related surgeries or diagnostic biopsies);
  • Preoperative assessment indicates the tumor is unresectable;
  • Viral load limitations: hepatitis B virus (HBV) DNA > 2000 copies/ml, hepatitis C virus (HCV) RNA > 1000;
  • Long-term hormone users require ongoing systemic hormone treatment (equivalent to > 10 mg prednisone/day) or any other form of immunosuppressive therapy;
  • Clinical significant bleeding events or bleeding tendencies within 3 months prior to enrollment or currently receiving thrombolytic or anticoagulant treatment;
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  • History of autoimmune diseases such as systemic lupus erythematosus, rheumatoid arthritis, etc.;
  • Active severe clinical infection (> Grade 2, NCI-CTCAE Version 5.0), including active tuberculosis; history of active tuberculosis infection within the past year without receiving formal anti-tuberculosis treatment or ongoing active tuberculosis; known or suspected active autoimmune diseases;
  • Uncontrolled diabetes (fasting blood glucose ≥ 10 mmol/L), severe lung disease (such as acute lung disease, pulmonary fibrosis affecting lung function, interstitial lung disease. However, resolved radiation pneumonitis is excluded);
  • Clinically significant cardiovascular disease; hypertension that is poorly controlled by antihypertensive medications (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg);
  • Recipients of renal replacement therapy;
  • History of other malignancies within the last 5 years. However, cured skin basal cell carcinoma or cervical carcinoma in situ is excluded;
  • Other conditions that are expected to render the participant unable to tolerate surgical treatment;
  • Allergic reactions to any components of the study drug;
  • Presence of alcohol dependence, mental illnesses, pregnancy (or breastfeeding), or other conditions that make participation in clinical trials inappropriate.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Yuhua Prof. Zhang, M.D. contact

+86-0571-88128058

drzhangyuhua@126.com

Jia Wu contact

+86-0571-88128058

wujia@zjcc.org.cn

China2 sites, 2 recruiting

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310002

    Chaoqun Fei, M.D., +086-0571-88123728, feicq@zjcc.org.cn

    wujia@zjcc.org.cn

    Not yet recruiting

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310002

    Chaoqun Fei, +86-0571-88122167, feicq@zjcc.org.cn

    Yuhua Zhang, M.D.

    Recruiting

Other trials in China

About this study

Official title: Hepatic Arterial Infusion Chemotherapy and Immunotherapy (HAICI) as Neoadjuvant Treatment for Resectable Hepatocellular Carcinoma in BCLC A/B Stage Beyond Up to Seven Criteria: An Open-Label, Single-Arm, Pilot Study

Dear Sir/Madam, We would like to invite you to participate in this clinical research, which has been approved by the Medical Ethics Committee of Zhejiang Cancer Hospital. This informed consent form provides you with detailed information to help you decide whether or not to participate in this study. Please read it carefully, and ensure you fully understand it or get satisfactory answers to your questions before making your decision. If you have any questions, please feel free to consult the researchers, and we will provide you with comprehensive explanations.

Hepatic artery infusion chemotherapy (HAIC) has recently become a popular local treatment method for liver cancer. A large Phase III clinical study from Sun Yat-sen University Cancer Center demonstrated that in a randomized comparison of HAIC versus transarterial chemoembolization (TACE) for unresectable large hepatocellular carcinoma (≥7 cm), the objective response rate (ORR) for HAIC was 46%, while TACE had an ORR of only 18%, with a statistically significant difference between the two. Additionally, HAIC showed advantages over TACE in terms of progression-free survival (PFS) and overall survival (OS), reducing the risk of disease progression by 43% and the risk of death by 42%. In subgroups based on age, sex, performance status, alpha-fetoprotein levels, tumor size, and number of tumors, HAIC consistently demonstrated superior PFS and OS. A study from Taiwan indicated that for patients with advanced liver cancer with portal vein tumor thrombus, the ORR for the HAIC group reached 22.86%, compared to 26.09% for those using immune checkpoint inhibitors alone, and an ORR of 50.00% for the group receiving HAIC combined with immune checkpoint inhibitors.

Read more

FOLFOX (fluorouracil, leucovorin, and oxaliplatin) has shown positive results as a systemic treatment regimen for advanced liver cancer, with an ORR of 8.15%, a PFS of 2.93 months, and an OS of 6.47 months in comparative studies. When used as a treatment option in advanced liver cancer through hepatic artery infusion, its ORR increased to 31.5%, PFS to 7.8 months, and OS to 13.9 months.

Common immune checkpoint inhibitors include PD-1 monoclonal antibodies and PD-L1 monoclonal antibodies. PD-1 antibodies prevent immune evasion by blocking PD-1 on immune cells, while PD-L1 antibodies block PD-L1 on tumor cells to inhibit their interaction, thus preventing immune evasion. Therefore, PD-1 monoclonal antibodies primarily target immune cells, while PD-L1 monoclonal antibodies primarily target tumor cells. This leads us to attempt hepatic artery infusion of PD-L1 monoclonal antibodies, utilizing a high-concentration saturation infusion method to maximally block PD-L1 on tumor cells and reduce tumor immune evasion. Concurrently, combining FOLFOX-HAIC localized chemotherapy leads to the release of tumor necrosis antigens, facilitating immune system activity.

Thus, we aim to utilize hepatic artery infusion to deliver both PD-L1 monoclonal antibodies and chemotherapy into the liver, killing tumors with high concentrations of chemotherapy, which will lead to antigen release that aids subsequent immune drug effectiveness while reducing suppressive factors in the immune microenvironment, such as Tregs and M2 macrophages. This approach will help change the inhibitory status of the immune microenvironment and provide a foundation for subsequent immunotherapy.

In BCLC staging, stage A patients and some stage B patients have resectable liver cancer. However, factors affecting tumor staging, such as maximum tumor diameter and tumor quantity, are also considered high-risk recurrence factors in clinical models. Therefore, later tumor staging itself is a high-risk factor for tumor recurrence.

In 2009, Professor Mazzaferro and colleagues proposed the Up-to-Seven criteria (the sum of maximum tumor diameter and tumor number not exceeding 7). Patients who met this criteria and received liver transplantation had a five-year survival rate as high as 71%. Liver cancer patients exceeding the Up-to-Seven criteria are considered unsuitable candidates for liver transplantation, as exceeding this limit indicates a poor tumor biological behavior. Furthermore, the criteria align with the primary surgical treatment staging (CNLC Ia-IIa) recommended in the "Primary Liver Cancer Diagnosis and Treatment Guidelines (2024 Edition)" published by China's National Health Commission. Therefore, we plan to conduct a neoadjuvant study targeting resectable liver cancer exceeding the Up-to-Seven criteria, using hepatic artery chemotherapy combined with immune checkpoint inhibitor (PD-L1 monoclonal antibody) infusion as the treatment regimen.

Read the detailed description

Overall Design

  1. Screening Period For patients willing to participate in this clinical study, an informed consent form (in duplicate, with one copy kept by the researcher and one by the patient) will be signed. The researcher will screen for eligibility based on inclusion and exclusion criteria, with all screening tests to be completed between 28 and 0 days before treatment. Patients who meet the inclusion and exclusion criteria will enter the treatment phase.
  2. Neoadjuvant Treatment Period 2.1 Establishment of Arterial Infusion Pathway Interventional radiologists will be responsible for catheter placement through the femoral artery or distal radial artery, with the catheter tip adjusted in real-time under DSA monitoring to the distal end of the hepatic artery (beyond the bifurcation of the gastroduodenal artery). 2.2 Infusion of Hepatic Artery Chemotherapy Drugs and Immune Checkpoint Inhibitors Day 1: Adebrelimab 1200 mg, infused over 1 hour. Day 1: Oxaliplatin 85 mg/m², infused over 1-3 hours. Day 1: Calcium folinate 400 mg/m², infused over 3-4 hours. Day 1: 5-Fluorouracil 400 mg/m², bolus injection during the 4th hour (50 ml/min); 5-Fluorouracil 2400 mg/m², infused continuously for more than 46 hours. If a patient has two or more feeding arteries, consideration may be given to placing an infusion catheter in the main artery, while other arteries may use iodized oil, doxorubicin, or oxaliplatin for chemotherapy embolization. This treatment regimen is repeated every 3 weeks. An evaluation will be conducted at the end of each treatment cycle. Patients who achieve Objective Response Rate (ORR) will proceed to the surgical phase, where the researcher will determine whether to perform laparoscopic minimally invasive or open radical surgery. Patients who do not achieve ORR may undergo up to three additional cycles of treatment. Those who achieve ORR will undergo radical surgery three weeks after stopping the treatment. In cases where patients do not achieve ORR, the researcher will evaluate if radical surgery is feasible. If it is feasible, surgery will be performed three weeks after stopping treatment; if not, the patient will be submitted for multidisciplinary discussion regarding subsequent treatment plans. If surgery is delayed due to drug-related side effects within four weeks after obtaining ORR, it will be recorded as a surgical delay, and the time beyond this point will be noted as the duration of the surgery extension.
  3. Perioperative Period Complete preoperative assessments and evaluations will be conducted, with surgery performed using either minimally invasive or open techniques. The method of liver resection may be anatomical or non-anatomical resection.
  4. Postoperative Adjuvant Treatment Postoperative adjuvant treatment: Patients who achieve ORR in the neoadjuvant treatment phase will receive intravenous Adebrelimab 1200 mg every three weeks. Patients with postoperative pathological negative Microvascular Invasion (MVI) will continue treatment for six months, while those with positive MVI will continue for twelve months. For patients who did not achieve ORR but underwent surgical treatment, the subsequent adjuvant treatment plan will be discussed by the multidisciplinary team (MDT).
  5. Safety Follow-up 5.1 Pre-treatment Safety Follow-up: Ensure that the patient's physical condition is in a generally normal state before treatment. A complete blood count, biochemical tests, coagulation function, and electrocardiogram must be completed within seven days prior to treatment to ensure the patient's condition meets pre-treatment requirements. 5.2 Post-treatment Safety Follow-up: This follow-up is used to monitor damage to the patient's physical condition after treatment, facilitating early correction of any abnormalities. Blood counts and biochemical tests must be completed within three days after treatment; if there is bone marrow suppression or liver/kidney function damage, correction must be achieved before entering the next treatment phase. 5.3 Periodic Safety Follow-up: This is to monitor damage caused by the cumulative dose of treatment drugs. Tests will include chest CT, cardiac troponin, cortisol (8 AM), and thyroid function, with re-evaluation every treatment cycle.
  6. Survival Follow-up This study is exploratory, with the primary endpoint being Objective Response Rate (ORR). However, the time to recurrence (for patients who underwent surgery after neoadjuvant treatment) and progression-free survival (for patients who did not undergo surgery) will still be recorded for every patient participating in the study, as well as overall survival time.
Being tested
Adebrelimab, Oxaliplatin, Fluorouracil,Leucovorin
Keywords
Neoadjuvant therapy, Beyond up to seven, Hepatic arterial infusion chemotherapy and immunotherapy
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Adebrelimab, Oxaliplatin, Fluorouracil,LeucovorinDrug

    Chemotherapy drugs including Oxaliplatin, Fluorouracil,Leucovorin and immunotherapy durgs Adebrelimab will infuse to liver by transarterial catheter toward to the lesion.

Study groups in NCT06741020
Study groupRoleWhat they receive
HAICI groupExperimentalDay 1: Adebrelimab 1200mg, administer over 1 hour. Day 1: Oxaliplatin 85mg/m², administer over 1-3 hours; Day 1: Leucovorin calcium 400mg/m², administer over 3-4 hours; Day 1: Fluorouracil 400mg/m², administer as a bolus infusion (50ml/min) at the 4th hour; Fluorouracil 2400mg/m², continue infusion for more than 46 hours; If the patient has two or more supplying arteries, consider placing a perfusion catheter in the main artery for infusion, and use iodinated oil, doxorubicin or idarubicin, oxaliplatin, and other drugs for chemoembolization in other arteries. The above treatment regimen is repeated every 3 weeks for a treatment cycle.
Receives: Drug: Adebrelimab, Oxaliplatin, Fluorouracil,Leucovorin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective response rate (ORR)

    ORR, as determined based on tumor response according to RECIST 1.1, is defined as the proportion of all randomized subjects whose objective response is either a CR or PR.

    Measured: Up to 12 months

Secondary outcomes (4)

  1. Disease Control Rate(DCR)

    DCR is defined as the percentage of participants who have objective response of complete response (CR) or partial response (PR) or stable disease (SD) at the time of data cutoff as assessed by RECIST 1.1.

    Measured: Up to 12 months

  2. Time to Response (TTR)

    The duration between treatment start and achieve partial response or complete response.

    Measured: From date of first dose of study drug until achieveing objective response.

  3. Surgery Delay (SD)

    If surgery cannot be performed due to drug-related side effects within 4 weeks after obtaining the ORR, it is deemed a surgical delay, and the time exceeding this point will be recorded as the surgical extension time.

    Measured: Up to 6 months

  4. Treatment-related adverse events

    Safety will be evaluated according to the NCI-CTCAE Version 5.0.

    Measured: Up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Dec 2024
  2. Study start1 Mar 2025
  3. Primary completion30 Jun 2026 (estimated)
  4. Study completion30 Dec 2026 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Model description
Patients will receive A combination of Oxaliplatin, Calcium folinate, 5-Fluorouracil and Adebrelimab with transhepatic arterial infusion.
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06741020
Sponsor's protocol ID
IIT-2024-413
Acronym
HAICI
Status last verified
May 2025
First submitted
14 Dec 2024
Last updated
23 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Mazzaferro V, Llovet JM, Miceli R, Bhoori S, Schiavo M, Mariani L, Camerini T, Roayaie S, Schwartz ME, Grazi GL, Adam R, Neuhaus P, Salizzoni M, Bruix J, Forner A, De Carlis L, Cillo U, Burroughs AK, Troisi R, Rossi M, Gerunda GE, Lerut J, Belghiti J, Boin I, Gugenheim J, Rochling F, Van Hoek B, Majno P; Metroticket Investigator Study Group. Predicting survival after liver transplantation in patients with hepatocellular carcinoma beyond the Milan criteria: a retrospective, exploratory analysis. Lancet Oncol. 2009 Jan;10(1):35-43. doi: 10.1016/S1470-2045(08)70284-5. Epub 2008 Dec 4.

    PubMed 19058754

  • Yang P, Qiu J, Li J, Wu D, Wan X, Lau WY, Yuan Y, Shen F. Nomograms for Pre- and Postoperative Prediction of Long-term Survival for Patients Who Underwent Hepatectomy for Multiple Hepatocellular Carcinomas. Ann Surg. 2016 Apr;263(4):778-86. doi: 10.1097/SLA.0000000000001339.

    PubMed 26135698

  • Shen L, Qi H, Chen S, Cao F, Xie L, Wu Y, Ma W, Song Z, Yuan H, Zhang T, Li D, Wen X, Chen Q, Li W, Zhang X, Fan W. Cryoablation combined with transarterial infusion of pembrolizumab (CATAP) for liver metastases of melanoma: an ambispective, proof-of-concept cohort study. Cancer Immunol Immunother. 2020 Sep;69(9):1713-1724. doi: 10.1007/s00262-020-02566-z. Epub 2020 Apr 24.

    PubMed 32333081

  • Lyu N, Wang X, Li JB, Lai JF, Chen QF, Li SL, Deng HJ, He M, Mu LW, Zhao M. Arterial Chemotherapy of Oxaliplatin Plus Fluorouracil Versus Sorafenib in Advanced Hepatocellular Carcinoma: A Biomolecular Exploratory, Randomized, Phase III Trial (FOHAIC-1). J Clin Oncol. 2022 Feb 10;40(5):468-480. doi: 10.1200/JCO.21.01963. Epub 2021 Dec 14.

    PubMed 34905388

  • Wu JS, Hong TC, Wu HT, Lin YJ, Chang TT, Wang CT, Liu WC, Hsieh MT, Wu IC, Chen PJ, Chen CY, Lin SH, Chuang CH, Han MZ, Chen HP, Tsai HM, Kuo HY. Hepatic arterial infusion chemotherapy and immune checkpoint inhibitors, alone or in combination, in advanced hepatocellular carcinoma with macrovascular invasion: a single-centre experience in Taiwan. J Gastrointest Oncol. 2023 Apr 29;14(2):849-862. doi: 10.21037/jgo-22-858. Epub 2023 Apr 10.

    PubMed 37201085

  • Li QJ, He MK, Chen HW, Fang WQ, Zhou YM, Xu L, Wei W, Zhang YJ, Guo Y, Guo RP, Chen MS, Shi M. Hepatic Arterial Infusion of Oxaliplatin, Fluorouracil, and Leucovorin Versus Transarterial Chemoembolization for Large Hepatocellular Carcinoma: A Randomized Phase III Trial. J Clin Oncol. 2022 Jan 10;40(2):150-160. doi: 10.1200/JCO.21.00608. Epub 2021 Oct 14.

    PubMed 34648352

  • Xia Y, Tang W, Qian X, Li X, Cheng F, Wang K, Zhang F, Zhang C, Li D, Song J, Zhang H, Zhao J, Yao A, Wu X, Wu C, Ji G, Liu X, Zhu F, Qin L, Xiao X, Deng Z, Kong X, Li S, Yu Y, Xi W, Deng W, Qi C, Liu H, Pu L, Wang P, Wang X. Efficacy and safety of camrelizumab plus apatinib during the perioperative period in resectable hepatocellular carcinoma: a single-arm, open label, phase II clinical trial. J Immunother Cancer. 2022 Apr;10(4):e004656. doi: 10.1136/jitc-2022-004656.

    PubMed 35379737

  • Marron TU, Fiel MI, Hamon P, Fiaschi N, Kim E, Ward SC, Zhao Z, Kim J, Kennedy P, Gunasekaran G, Tabrizian P, Doroshow D, Legg M, Hammad A, Magen A, Kamphorst AO, Shareef M, Gupta NT, Deering R, Wang W, Wang F, Thanigaimani P, Mani J, Troncoso L, Tabachnikova A, Chang C, Akturk G, Buckup M, Hamel S, Ioannou G, Hennequin C, Jamal H, Brown H, Bonaccorso A, Labow D, Sarpel U, Rosenbloom T, Sung MW, Kou B, Li S, Jankovic V, James N, Hamon SC, Cheung HK, Sims JS, Miller E, Bhardwaj N, Thurston G, Lowy I, Gnjatic S, Taouli B, Schwartz ME, Merad M. Neoadjuvant cemiplimab for resectable hepatocellular carcinoma: a single-arm, open-label, phase 2 trial. Lancet Gastroenterol Hepatol. 2022 Mar;7(3):219-229. doi: 10.1016/S2468-1253(21)00385-X. Epub 2022 Jan 20.

    PubMed 35065058

  • Zhou WP, Lai EC, Li AJ, Fu SY, Zhou JP, Pan ZY, Lau WY, Wu MC. A prospective, randomized, controlled trial of preoperative transarterial chemoembolization for resectable large hepatocellular carcinoma. Ann Surg. 2009 Feb;249(2):195-202. doi: 10.1097/SLA.0b013e3181961c16.

    PubMed 19212170

  • Gosavi R, Chia C, Michael M, Heriot AG, Warrier SK, Kong JC. Neoadjuvant chemotherapy in locally advanced colon cancer: a systematic review and meta-analysis. Int J Colorectal Dis. 2021 Oct;36(10):2063-2070. doi: 10.1007/s00384-021-03945-3. Epub 2021 May 4.

    PubMed 33945007

  • De Lena M, Zucali R, Viganotti G, Valagussa P, Bonadonna G. Combined chemotherapy-radiotherapy approach in locally advanced (T3b-T4) breast cancer. Cancer Chemother Pharmacol. 1978;1(1):53-9. doi: 10.1007/BF00253147.

    PubMed 373908

  • Xia YX, Zhang F, Li XC, Kong LB, Zhang H, Li DH, Cheng F, Pu LY, Zhang CY, Qian XF, Wang P, Wang K, Wu ZS, Lyu L, Rao JH, Wu XF, Yao AH, Shao WY, Fan Y, You W, Dai XZ, Qin JJ, Li MY, Zhu Q, Wang XH. [Surgical treatment of primary liver cancer:a report of 10 966 cases]. Zhonghua Wai Ke Za Zhi. 2021 Jan 1;59(1):6-17. doi: 10.3760/cma.j.cn112139-20201110-00791. Chinese.

    PubMed 33412628

  • Zeng H, Chen W, Zheng R, Zhang S, Ji JS, Zou X, Xia C, Sun K, Yang Z, Li H, Wang N, Han R, Liu S, Li H, Mu H, He Y, Xu Y, Fu Z, Zhou Y, Jiang J, Yang Y, Chen J, Wei K, Fan D, Wang J, Fu F, Zhao D, Song G, Chen J, Jiang C, Zhou X, Gu X, Jin F, Li Q, Li Y, Wu T, Yan C, Dong J, Hua Z, Baade P, Bray F, Jemal A, Yu XQ, He J. Changing cancer survival in China during 2003-15: a pooled analysis of 17 population-based cancer registries. Lancet Glob Health. 2018 May;6(5):e555-e567. doi: 10.1016/S2214-109X(18)30127-X.

    PubMed 29653628

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Adebrelimab, Oxaliplatin, Fluorouracil,Leucovorin in people with Hepatocellular Carcinoma (HCC), run by Zhejiang Cancer Hospital at 2 sites 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 9 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

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?

Contact Yuhua Prof. Zhang, M.D. (+86-0571-88128058, drzhangyuhua@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (ORR) (time frame: Up to 12 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 NCT06741020, which also lists 13 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 23 May 2025.

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