Anti-angiogenic Agents Plus Anti-PD-1 Antibodies for uHCC

NCT04639284 | Unknown

• 1 other identifier: COMOHCC
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Combination treatment with antiangiogenic agents and anti-programmed cell death protein 1 (PD-1) antibodies have shown high anti-tumor efficacy for patients with unresectable or advanced hepatocellular carcinoma (uHCC). In this single-center cohort study, we are aiming to (1) evaluate the clinical effectiveness in real-world patients, especially for Chinese patients, most of whom were with hepatitis B virus infection; (2) predict clinical effectiveness with clinicopathological features; (3) predict clinical effectiveness with histologic features and blood samples.

Conditions

Hepatocellular Carcinoma

Keywords

anti-angiogenic; PD-1 antibody; lenvatinib; PD-L1 antibody

Outcome Measures

Primary Outcomes (1)

• Objective response

  Subjects with complete response or partial response

  up to 2 years

Secondary Outcomes (6)

• Duration of response

  up to 2 years

• Progression free survival

  up to 2 years

• Overall survival

  up to 2 years

• Ratio of R0 resection

  up to 2 years

• Recurrence-free survival

  up to 5 years

Study Arms (1)

Combinational therapy

Participants who receive systemic treatment with an anti-angiogenic agent, including sorafenib, lenvatinib, apatinib, and bevacizumab, in combination with an anti-PD-1/PD-L1 antibody, including pembrolizumab, nivolumab, sintilimab, toripalimab, camrelizumab, tislelizumab, and atezolizumab.

Drug: Anti-angiogenic agents plus anti-PD-1/PD-L1 antibodies

Interventions

Anti-angiogenic agents plus anti-PD-1/PD-L1 antibodies DRUG

Combination therapies with an anti-angiogenic agent (tyrosine kinase inhibitor or VEGF/VEGFR antibody) and an anti-PD-1/PD-L1 antibody.

Combinational therapy

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Unresectable or advanced HCC patients who received the combination therapy with an anti-angiogeic agent and an anti-PD-1/PD-L1 agent.

You may qualify if:

• Documented diagnosis of HCC confirmed by histology/cytology or clinical diagnosis of HCC by Guidelines for Diagnosis and Treatment of Primary Liver Cancer in China (2019 edition) criteria.
• Unresectable or advanced disease at the investigator's discretion. The advanced stage was BCLC C stage or China Liver Cancer Stage IIIa or IIIb.
• Child-Pugh class A or B7.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
• Subjects received combination therapy with an anti-angiogenic agent and an anti-PD-1/PD-L1 antibody, received at least one imaging evaluation, and signed an Informed Consent Form. Anti-angiogenic agents include sorafenib, lenvatinib, apatinib, and bevacizumab; anti-PD-1/PD-L1 antibodies include pembrolizumab, nivolumab, sintilimab, toripalimab, camrelizumab, tislelizumab, and atezolizumab.
• Adequate hematologic and end-organ function.

You may not qualify if:

• Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
• History of malignancy other than HCC within 5 years prior to the therapy, with the exception of adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or papillary thyroid carcinoma.
• History of organ transplantation or hepatic encephalopathy.
• Allergic to anti-angiogenic agents or anti-PD-1/PD-L1 agents.
• History of gastrointestinal perforation and/or fistula within the 6 months, a history of intestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive bowel resection, Crohn's disease, ulcerative colitis, or chronic diarrhea within 6 months.
• Active autoimmune disease requiring systemic therapy within 2 years prior to the first dose, allowing the use of alternative therapies (e.g., thyroxine, insulin, or physiologic corticosteroids for adrenal or pituitary insufficiency); history of primary immunodeficiency; presence of only autoimmune antibody-positive subjects. The presence of autoimmune disease needs to be confirmed at the investigator's discretion.
• Uncontrollable hypertension, SBP \>140 mmHg or DBP \>90 mmHg after optimal medical therapy, hypertensive crisis, or history of hypertensive encephalopathy.
• Subjects had a bleeding event in the past 6 months due to esophageal or gastric fundus varices induced by portal venous hypertension; subjects have undergone a gastrointestinal endoscopy within 3 months prior to the first dose to diagnose the presence of severe (G3) varices; subjects had a high risk of bleeding as assessed by the investigator.
• Subject requests withdrawal of informed consent.
• Other conditions that the investigator deems inappropriate for participation in this study.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Tissue specimens and blood specimens

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Angiogenesis Inhibitors

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

Intervention Hierarchy (Ancestors)

Angiogenesis Modulating Agents; Growth Substances; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Growth Inhibitors; Antineoplastic Agents; Therapeutic Uses

Study Officials

• Hui-Chuan Sun, MD, PhD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiao-Dong Zhu

CONTACT

+862164037181; zhuxiaodong@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: November 19, 2020
• First Posted: November 20, 2020
• Study Start: December 23, 2020
• Primary Completion: July 31, 2022
• Study Completion: July 31, 2023
• Last Updated: July 26, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)