Suspended

A Exploratory Study of Apatinib Adjuvant Therapy for Hepatocellular Carcinoma With Portal Vein Invasion Who Underwent Radical Resection

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What is being tested

Apatinib

Drug
Who is being recruted

Adenocarcinoma+8

+ Carcinoma

+ Digestive System Diseases

From 18 to 70 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: July 2017
See protocol details

Summary

Principal SponsorShanghai Zhongshan Hospital
Study ContactXiao-Dong Zhu
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 20, 2017

Actual date on which the first participant was enrolled.

Portal vein tumor thrombus (PVTT) is one of the characteristics of advanced stage for patients with hepatocellular carcinoma (HCC). There's limited treatment choice for these patients. Even for those who underwent curative resection (R0 resection), the recurrence rate was extremely high. Apatinib is a highly selective VEGFR2 inhibitor and reduces the angiogenesis of tumor efficiently, which had been proven effective in many solid tumors, is a Chinese domestic TKI targeting vascular endothelial growth factor receptor. Phase 2 study of apatinib for patients with advanced HCC had shown signals of clinical efficacy and modest safety. In this study, we aim to evaluate the effects and safety of adjuvant apatinib therapy for the patients who underwent R0 resection for HCC with PVTT.

Official TitleA Exploratory Study of Apatinib Adjuvant Therapy for Hepatocellular Carcinoma With Portal Vein Invasion Who Underwent Radical Resection
NCT03261791
Principal SponsorShanghai Zhongshan Hospital
Study ContactXiao-Dong Zhu
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

30 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AdenocarcinomaCarcinomaDigestive System DiseasesDigestive System NeoplasmsCarcinoma, HepatocellularLiver DiseasesLiver NeoplasmsNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Glandular and Epithelial

Criteria

Inclusion Criteria: 1. Aged from 18-70 years. 2. HCC diagnosis confirmed by pathological examination who did not receive anti-tumor treatment (anti-tumor treatment including but not limited to: local ablation therapy, TACE, radiation therapy, chemotherapy, targeted drug therapy, etc.) 3. Underwent radical resection for hepatocellular carcinoma with portal vein tumor thrombus, as assessed by preoperative imaging or intraoperative findings, within 4 weeks 4. Child-Pugh class: A or B7 5. The ECOG: 0-1 points 6. The expected survival time ≥ 6 months. 7. Main organs function is normal including: * blood routine examination * HB ≥ 90 g/L * ANC ≥ 1.5×109 /L * PLT ≥ 80×109/L * biochemical test * ALB ≥ 29 g/L * ALT\<3 ULN and AST\< 3 ULN * TBIL ≤ 1.5 ULN * Serum creatinine ≤ 1.5 ULN; 8. Women of childbearing age must have pregnancy tests (serum or urine) within 7 days prior to admission, and the results are negative and are willing to use appropriate methods of contraception at 8 weeks after the trial and at the end of the test. For men, surgical sterilization should be applied, or consent to the appropriate method of contraception 8 weeks after the trial and at the end of the trial; 9. subjects voluntarily joined the study, signed informed consent, good compliance, and followed up. Exclusion Criteria: 1. Hepatic duct carcinoma、mixed cell carcinoma and fiberboard layer cell carcinoma which have confirmed; Past (5 years) or current with other malignant tumor, except skin basal cell carcinoma and cervical carcinoma in situ. 2. Patients with hypertension who are unable to fall within normal range by antihypertensive medications (systolic pressure \> 140 mmHg, diastolic pressure \> 90 mmHg). 3. With the second level of myocardial ischemia or myocardial infarction, poor control of the arrhythmia (including QTc interval = 450 ms, male female = 470 ms). 4. Factors that affect oral medication, such as inability to swallow, chronic diarrhea and intestinal obstruction, which significantly affect the use and absorption of drugs. 5. Ascites with clinical symptoms requires therapeutic peritoneal paracentesis or drainage. 6. In the past 6 months, with the history of alimentary tract hemorrhage or definite gastrointestinal bleeding tendency, such as: the risk of bleeding esophageal varices, local active ulcerative lesions, fecal occult blood; For those with fecal occult blood (+), gastroscopy is required. 7. Abdominal fistula, gastrointestinal perforation, or abdominal abscess occurred within 28 days before entry; 8. Postoperative complications were not relieved. 9. Abnormal coagulation function (INR \> 1.5 or prothrombin time (PT) \> ULN+4 seconds), with bleeding tendency or undergoing thrombolysis or anticoagulant therapy; 10. Past and present pulmonary fibrosis history, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug associated pneumonia, and severe lung function impairment; 11. Urine routine showed that urinary protein is more than + + or confirmed 24 hours urine protein is more than 1.0 g; 12. Symptomatic metastasis of the central nervous system; 13. Pregnant or lactating women; fertile patients who are unwilling or unable to adopt effective contraceptives; 14. Patient with mental illness or a history of psychotropic substance abuse; 15. HIV infection; 16. Before operation, AFP or PIVKA-2 increased, but not decreased to normal range; 17. HBV-DNA\>10\^3 copys/ml; 18. Other conditions that the investigators considered that not unsuitable for inclusion.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Apatinib mesylate tablets 500 mg po qd.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Zhongshan Hospital

Shanghai, ChinaOpen Zhongshan Hospital in Google Maps
SuspendedOne Study Center