Neoplasms

All Conditions

Digestive System Diseases

Carcinoma

Carcinoma, Hepatocellular

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Micronutrients

All Drugs and Chemicals

Antineoplastic Agents

Hematinics

Vitamins

Leucovorin

Fluorouracil

Oxaliplatin

Sorafenib

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Antidotes

Protective Agents

Folic Acid

Vitamin B Complex

Trace Elements

Protein Kinase Inhibitors

Enzyme Inhibitors

Folate

Vitamin B9

Sorafenib combined with Hepatic arterial infusion chemotherapy with Oxaliplatin

Sorafenib combined with Hepatic arterial infusion chemotherapy with Oxaliplatin, Fluorouracil and Leucovorin

administration of Oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries

HAIC of FOLFOX

administration of Oxaliplatin via the tumor feeding arteries

HAIC of OXA

Ming Shi

Ping Rong, Guo

Yuanmin Zhou, MD

Jinghua Chen, MD

WanQiang Fang, MD

The purpose of this study is to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy (HAIC) of oxaliplatin plus fluorouracil/leucovorin compared with HAIC of oxaliplatin alone in patients with advanced hepatocellular carcinoma (HCC)

Sorafenib is the most widely used palliative treatment for advanced hepatocellular carcinoma (HCC) patients . Our previous prospective study revealed that sorafenib combined with hepatic arterial infusion chemotherapy (HAIC) of oxaliplatin plus fluorouracil/leucovorin confer a survival benefit to advanced HCC . However, HAIC of fluorouracil is not such for advanced HCC. Whether HAIC of oxaliplatin is as effective as HAIC of oxaliplatin plus fluorouracil/leucovorin is controversial. Thus, the investigators carried out this prospective randomized control study to find out it.

Phase 2 Study of Sorafenib Plus HAIC of FOLFOX vs. Sorafenib Plus HAIC of OXA for Advanced HCC

Sorafenib Plus Hepatic Artery Infusion Chemotherapy of Oxaliplatin, Fluorouracil/Leucovorin Versus Sorafenib Plus Hepatic Artery Infusion Chemotherapy of Oxaliplatin for Advanced Hepatocellular Carcinoma

PFS was defined as the time from the date of randomization to the date of first documentation of disease progression based on modified Response Evaluation Criteria in Solid Tumors (mRECIST), or date of death, whichever occurred first.

OS was defined as the duration from the date of randomization until the date of death from any cause. Participants who were lost to follow-up were censored at the last date the participant was known to be alive, and participants who remained alive were censored at the time of data cutoff.

ORR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR) based on mRECIST. CR was defined as disappearance of any intratumoral arterial enhancement in all target lesions. PR was defined as at least a 30% decrease in the sum of diameters of viable (enhancement of arterial phase) target lesions taking as reference to the baseline sum of the diameters of target lesions.

Number of adverse events. Postoperative adverse events were graded based on CTCAE v4.03

Kaiping Central Hospital

Guangzhou No.12 People's Hospital

Sun Yat-sen University

Clinical Professor

Infections

Adenoviridae Infections

Liver Extracts

Patients receive oxaliplatin, 5-fluorouracil and leucovorin and recombinant human type-5 adenovirus 0.5ml via hepatic artery

Patients receive oxaliplatin, 5-fluorouracil and leucovorin and normal saline via hepatic artery

Patients receive H101 0.5ml dissolved in 10ml normal saline in each session of HAIC

H101

Patients receive normal saline 10ml in each session of HAIC

Placebos

Ming Shi, MD

Hepatic artery infusion chemotherapy (HAIC) is effective and safe for hepatocellular carcinoma (HCC). Recombinant Human Type-5 Adenovirus (H101) is safe for HCC. The purpose of this study is to evaluate the efficacy and safety of HAIC combined with H101 compared with HAIC alone in patients with unresectable hepatocellular carcinoma (HCC) at barcelona clinic liver cancer A-B stage.

HAIC Plus H101 vs HAIC Alone for Unresectable HCC at BCLC A-B

Hepatic Artery Infusion Chemotherapy Plus Recombinant Human Type-5 Adenovirus vs Hepatic Artery Infusion Chemotherapy Alone for Unresectable Hepatocellular Carcinoma at Barcelona Clinic Liver Cancer A-B Stage

Postoperative adverse events were graded based on CTCAE v4.03

Proffessor

Rare Diseases

Cholangiocarcinoma

Virus Diseases

Bile Duct Cancer

Intrahepatic Cholangiocarcinoma

Bone Density Conservation Agents

Levoleucovorin

Calcium

Calcium, Dietary

Folinic Acid

Recombinant Human Adenovirus Type 5 (H101): intratumorally injected 3 days before HAIC. 1 vial (5.0 × 10\^11 vp) if the maximum diameters of lesion ≤ 5 cm, 2 vials (1.0 × 10\^12 vp) if the maximum diameters of lesion ≤ 10 cm, 3 vials (1.5 × 10\^12 vp) if the maximum diameters of lesion is \> 10 cm.

HAIC (FOLFOX): Oxaliplatin 50 mg + 5-FU 1.5 g + leucovorin calcium

H101 will be intratumorally injected 3 days before HAIC. Dosage of H101: 1 vial (5.0 × 10\^11 vp) if the maximum diameters of lesion ≤ 5 cm, 2 vials (1.0 × 10\^12 vp) if the maximum diameters of lesion ≤ 10 cm, 3 vials (1.5 × 10\^12 vp) if the maximum diameters of lesion is \> 10 cm.

Recombinant Human Adenovirus Type 5

Oxaliplatin 50 mg + 5-FU 1.5 g + leucovorin calcium. The infusion will be continued for 2-3 days according to patients' tolerance and tumor conditions. The standard treatment for HAIC consists of 4-6 cycles, with the second cycle being 3 weeks after the end of the first HAIC cycle and the subsequent cycles being 4 weeks after the end of the previous HAIC.

Wang Tianxiao, MD

ZHANG YUEWEI, MD

Oncolytic viruses can selectively replicate in and destroy tumor cells. Recent studies indicate that recombinant human adenovirus type 5 (H101), which is the first approved oncolytic virus drug in the world, shows anti-tumor effects on liver cancer. This study aims to further verify the effect and safety of recombinant human adenovirus type 5 combined with HAIC in the treatment of intrahepatic mass-forming cholangiocarcinoma.

This is a perspective, single-arm trial. According to previous studies, the PFS of HAIC for unresectable intrahepatic cholangiocarcinoma is approximately 8 - 10 months, and one year progression free rate is about 40%. We assumed that the study could detect 20% absolute difference and 1 year PFS rate could achieve 60% PFS by (FOLFOX + H101) over conventional HAIC (FOLFOX). Simon's two-stage design is used to estimate the sample size, with α value of 0.05 and power of 0.9. A total sample size of 66 participants are required.

Recombinant Human Adenovirus Type 5 Plus HAIC of FOLFOX for Intrahepatic Cholangiocarcinoma

Recombinant Human Adenovirus Type 5 Combined With Hepatic Artery Infusion Chemotherapy of FOLFOX in Patients With Intrahepatic Mass-forming Cholangiocarcinoma: a Single-site, Single-arm, Prospective Study

The median amount of time from registration until disease progression or death, whichever occurs first. Disease progression was assessed via RECIST 1.1 criteria.

The percentage of participants who are alive one year after the start of the treatment.

The percentage of participants who have achieved either a complete or partial response, as assessed by Response Criteria in Solid Tumors (RECIST 1.1).

The percentage of participants who have achieved complete response, partial response and stable disease, as assessed by Response Criteria in Solid Tumors (RECIST 1.1).

Beijing Tsinghua Chang Gung Hospital

Chlorotrianisene

Hepatic arterial infusion chemotherapy with oxaliplatin, leucovorin, and 5-fluorouracil

administration of oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries

To evaluate safety and efficacy of combined hepatic arterial infusion chemotherapy (HAIC) of oxaliplatin, 5-fluorouracil and leucovorin and sorafenib in hepatocellular carcinoma (HCC) refractory to transarterial chemoembolization(TACE)

In most current guidelines, sorafenib is considered as the second-line treatment for patients with transarterial chemoembolization(TACE) failure or refractoriness.However,the median overall survival of those treated with sorafenib monotherapy was 16.4 to 24.7 months.

Whether combining sorafenib with hepatic arterial infusion chemotherapy(HAIC) of oxaliplatin,5-fluorouracil and leucovorin is safe, well tolerated, and efficacious remains unknown, with no prospective clinical data currently available.The investigators therefore conducted a prospective and randomized phase II trial to compare the safety and efficacy of HAIC with sorafenib in patients refractory to TACE

Phase Ⅱ Study of HAIC of FOLFOX vs. Sorafenib in HCC Refractory to TACE

Randomized Phase Ⅱ Study of Second-line Treatment Comparing Hepatic Arterial Infusion Chemotherapy of Oxaliplatin, 5-fluorouracil and Leucovorin With Sorafenib in Hepatocellular Carcinoma Refractory to Transarterial Chemoembolization

The period from the date of the start of HAIC or sorafenib until the date of the confirmation of tumor progression or death

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Phase 2 Study of Sorafenib Plus HAIC of FOLFOX vs. Sorafenib Plus HAIC of OXA for Advanced HCC	NCT03812770	Hepatocellular ...	Sorafenib HAIC of FOLFOX HAIC of OXA	18 Years - 75 Years	Sun Yat-sen University
HAIC Plus H101 vs HAIC Alone for Unresectable HCC at BCLC A-B	NCT03780049	Hepatocellular ...	HAIC of FOLFOX H101 Placebos	18 Years - 75 Years	Sun Yat-sen University
Recombinant Human Adenovirus Type 5 Plus HAIC of FOLFOX for Intrahepatic Cholangiocarcinoma	NCT05124002	Cholangiocarcin...	Recombinant Hum... HAIC of FOLFOX	18 Years -	Beijing Tsinghua Chang Gung Hospital
Phase Ⅱ Study of HAIC of FOLFOX vs. Sorafenib in HCC Refractory to TACE	NCT03722498	Hepatocellular ...	HAIC of FOLFOX Sorafenib	18 Years - 75 Years	Sun Yat-sen University
HAIC Plus H101 vs HAIC Alone for Unresectable HCC at BCLC A-B	NCT03780049	Hepatocellular ...	HAIC of FOLFOX H101 Placebos	18 Years - 75 Years	Sun Yat-sen University
Phase 2 Study of Sorafenib Plus HAIC of FOLFOX vs. Sorafenib Plus HAIC of OXA for Advanced HCC	NCT03812770	Hepatocellular ...	Sorafenib HAIC of FOLFOX HAIC of OXA	18 Years - 75 Years	Sun Yat-sen University
Phase 2 Study of Sorafenib Plus HAIC of FOLFOX vs. Sorafenib Plus HAIC of OXA for Advanced HCC	NCT03812770	Hepatocellular ...	Sorafenib HAIC of FOLFOX HAIC of OXA	18 Years - 75 Years	Sun Yat-sen University

Spots Global Cancer Trial Database for haic of folfox