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

Last updated: July 23, 2021
Sponsor: Shanghai Zhongshan Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Liver Disorders

Liver Cancer

Abdominal Cancer

Treatment

N/A

Clinical Study ID

NCT04639284
COMOHCC
  • Ages 18-90
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Documented diagnosis of HCC confirmed by histology/cytology or clinical diagnosis ofHCC by Guidelines for Diagnosis and Treatment of Primary Liver Cancer in China (2019edition) criteria.
  2. Unresectable or advanced disease at the investigator's discretion. The advanced stagewas BCLC C stage or China Liver Cancer Stage IIIa or IIIb.
  3. Child-Pugh class A or B7.
  4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
  5. Subjects received combination therapy with an anti-angiogenic agent and ananti-PD-1/PD-L1 antibody, received at least one imaging evaluation, and signed anInformed 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.
  6. Adequate hematologic and end-organ function.

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 200
Study Start date:
December 23, 2020
Estimated Completion Date:
July 31, 2023

Study Description

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. To evaluate the clinical effectiveness in real-world patients, especially for Chinese patients most of whom were with hepatitis B virus infection.

  2. To predict clinical effectiveness with clinicopathological features, such as lab examinations (at baseline and dynamic changes), radiological features (radiomics study at the baseline);

  3. To predict clinical effectiveness with histologic features, such as PD-L1 expression, ctDNA, and peripheral immune cell subtypes.

  4. To evaluate the clinical effectiveness of second- or third-line therapies, including TACE, HAIC, and interferon, for those who lost clinical benefit or who were intolerant to the combination therapy.

Connect with a study center

  • Zhongshan Hospital, Fudan University

    Shanghai, Shanghai 200032
    China

    Active - Recruiting

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