NCT05010434

Brief Summary

The purpose of this study is to investigate both the efficacy and safety of sintilimab combined with bevacizumab and radiotherapy in advanced hepatocellular carcinoma.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
46

participants targeted

Target at P50-P75 for phase_2 hepatocellular-carcinoma

Timeline
Completed

Started Aug 2021

Shorter than P25 for phase_2 hepatocellular-carcinoma

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 14, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

August 16, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 18, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

September 21, 2023

Status Verified

September 1, 2023

Enrollment Period

2 years

First QC Date

August 14, 2021

Last Update Submit

September 18, 2023

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

  • ORR (objective response rate)

    the proportion of patients who have a partial or complete response to therapy.

    through study completion, up to 2 year

Secondary Outcomes (5)

  • PFS (progression-free survival)

    through study completion, up to 2 year

  • OS (overall survival)

    through study completion, up to 2 year

  • DCR (disease control rate)

    through study completion, up to 2 year

  • LCR (local control rate)

    through study completion, up to 2 year

  • Adverse effects

    through study completion, up to 2 year

Study Arms (1)

Sintilimab and Bevacizumab Combined with Radiotherapy

EXPERIMENTAL
Drug: Sintilimab and Bevacizumab Combined with Radiotherapy

Interventions

Sintilimab and Bevacizumab Combined with RadiotherapyDRUG

Before radiotherapy: Bevacizumab+Sintilizumab, Q3w, 2 cycles in total. Radiation therapy: 30-50Gy/10 fractions. After radiotherapy: Bevacizumab+Sintilizumab, Q3w until disease progression or toxicity is intolerable.

Sintilimab and Bevacizumab Combined with Radiotherapy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-75 years;
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
  • Treatment-naïve primary HCC (consistent with the American Association for the Study of Liver Diseases 2018 Guideline on Liver Cancer Diagnosis (18)) or initial recurrent HCC after radical resection without any postoperative anti-cancer treatment;
  • At least one measurable lesion in the liver on the basis of modified Response Evaluation Criteria in Solid Tumors (mRECIST);
  • Presented with Cheng's type I/II/III PVTT;
  • Largest tumor size ≤ 10 cm, number of tumors ≤ 3, and remnant liver volume ≥ 50%;
  • Child-Pugh class A;
  • Adequate hematological, liver, renal function:
  • hemoglobin concentration ≥ 90 g/L;
  • neutrophil count ≥ 1.5×109/L;
  • platelet count ≥ 60×109/L;
  • AST and ALT ≤ 3×upper limit of normal (ULN)
  • total bilirubin ≤ 1.5×ULN;
  • serum creatinine ≤ 1.5×ULN;
  • serum albumin concentration ≥ 30 g/L;
  • +1 more criteria

You may not qualify if:

  • Tumor invasion of the superior mesenteric vein or bile ducts;
  • Infiltrative HCC;
  • Allergic to research reagents;
  • With other malignancies within 5 years;
  • With poorly controlled hypertension;
  • A past medical history of hepatic decompensation, such as hepatic encephalopathy, refractory ascites, and esophageal or gastric variceal bleeding;
  • A history of autoimmune disease;
  • Active infection requiring systemic treatments;
  • Severe bleeding;
  • With diseases needing daily non-steroidal anti-inflammatory drug (NSAID) therapy;
  • With other severe comorbidities.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

Location

Related Publications (1)

  • Zhu M, Liu Z, Chen S, Luo Z, Tu J, Qiao L, Wu J, Fan W, Peng Z. Sintilimab plus bevacizumab combined with radiotherapy as first-line treatment for hepatocellular carcinoma with portal vein tumor thrombus: A multicenter, single-arm, phase 2 study. Hepatology. 2024 Oct 1;80(4):807-815. doi: 10.1097/HEP.0000000000000776. Epub 2024 Feb 15.

    PMID: 38358542DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

sintilimabRadiotherapy

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 14, 2021

First Posted

August 18, 2021

Study Start

August 16, 2021

Primary Completion

September 1, 2023

Study Completion

September 1, 2023

Last Updated

September 21, 2023

Record last verified: 2023-09

Locations

CN(1)