A RCT of Oral S-1 in Combination With Sequential HAIC of Oxaliplatin After TACE in Patients With Advanced HCC

NCT01997957 | Unknown Phase 4

• 1 other identifier: OXALI_L_06366
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

Hepatocellular carcinoma (HCC) is one of the most commonly malignant tumors around the world and causes death of about 600000\~1000000 people each year. Since 1990s, hepatic carcinoma has become the second carcinoma killer in China. Surgical resection or liver transplantation is the only method possibly able to cure hepatic carcinoma. However, due to multiple tumors or poor hepatic function reserve in cirrhosis, surgical treatment is suitable for only a small portion of patients (11.9%-30.1%). Therefore, in clinical practice, transarterial chemoembolization (TACE) or transarterial embolization (TAE) is a preferential and standard treatment of unresectable advanced hepatic carcinoma and has notable advantages in controlling local tumors of the liver. Hepatic arterial infusion of oxaliplatin after TACE can significantly increase the local doses of chemotherapeutic agents in the liver, kill micrometastases and residual foci after embolization and demonstrate outstanding efficacy for treating concomitant portal and hepatic vein tumor thrombi. S-1 is a chemotherapeutic agent with convenient use and definite efficacy and, when used concomitantly with TACE, theoretically can not only effectively control intrahepatic foci but also prevent and control extrahepatic metastatic foci. However, this hasn't been verified in clinical application. This study is intended to investigate efficacy and safety of the combination treatment so as to provide a more effective and safety way for treating patients with advanced hepatic carcinoma (Barcelona stage-C patients with concomitant portal vein tumor thrombi or extrahepatic metastasis).

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular Carcinoma; Transarterial Chemoembolization; Hepatic Arterial Infusion Chemotherapy; Efficacy

Outcome Measures

Primary Outcomes (1)

• Time to progression(TTP)

  Time to clinically definite disease progression

  Up to 2 years

Secondary Outcomes (4)

• Overall survival(OS)

  Up to 2 years

• Response rate (RR)

  Up to 2 years

• Disease Control Rate (DCR)

  Up to 2 years

• Number of Participants with Serious and Non-Serious Adverse Events

  Up to 3 years

Study Arms (2)

TACE+HAIC-OXA+S-1

EXPERIMENTAL

Drug: S-1

TACE+HAIC-OXA

NO INTERVENTION

Interventions

S-1 DRUG

Begin oral administration of S-1 from the 2nd day after TACE therapy plus arterial indwelling catheter chemotherapy (Oxaliplatin)

TACE+HAIC-OXA+S-1

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signing the informed consent form;
• Diagnosed with HCC
• Patients with hepatic cirrhosis must comply with AASLD (American Association for the Study of Liver Diseases) diagnostic criteria:
• Typical radiological examination (ultrasonography, CT or MRI) manifestations: dynamic enhanced examination shows arterial-phase rapid heterogeneous enhancement and reduced venous-phase or delayed-phase rapid enhancement of space occupation in liver;
• If the diameter of space occupation in liver is ≥2cm, the diagnosis can be established if any of radiological examinations shows the above HCC characteristics;
• If the diameter of space occupation in liver is 1-2cm, the diagnosis can be established only when two radiological examinations show the above HCC characteristics;
• If the diameter of space occupation in liver is≤1cm, histopathological examination is needed for establishing the diagnosis.
• Histopathological examination is needed for establishing the diagnosis for patients without hepatic cirrhosis.
• Stage Barcelona C
• Grade A or B Child-Pugh score
• ECOG PS score is 0-1
• At least one measurable focus in liver according to (M) RECIST 1.0 criteria
• Male or female, age\>18
• Can orally take drugs
• Anticipated survival≥12 weeks

You may not qualify if:

• Early or middle-stage primary HCC
• Any contraindication of TACE therapy
• Known hepatofugal blood flow
• Known portal-systemic shunt
• Abnormal coagulation test (PLT\<6000/mm3, thrombogen activity\<50%)
• Renal failure or renal insufficiency necessitating dialysis
• Serious atherosclerosis
• Foci having undergone local treatment (e.g. resection, RFA, PEI or argon-helium cryoablation) cannot be used as the target foci
• History of heart diseases:
• Congestive heart failure of NYHA grade 2 above
• Symptomatic coronary artery disease
• Arrhythmia needing treatment with β blockers or drugs other than digoxin
• uncontrollable hypertension
• HIV infection or AIDS-related diseases
• Serious active infections other than hepatitis B and hepatitis C (NCI-CTCAE 4.0 grade 2 above)

Sponsors & Collaborators

• Zhu Xu: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

S 1 (combination)

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Zhu Xu, Master

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhu Xu, Master

CONTACT

0086-10-88196476; zhux387@263.net

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Interventional Therapy Department

Study Record Dates

• First Submitted: November 20, 2013
• First Posted: November 28, 2013
• Study Start: October 1, 2013
• Primary Completion: September 1, 2016
• Last Updated: November 28, 2013

Record last verified: 2013-11

Locations

CN (1)