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NCT06492408RecruitingPhase 2

Neoadjuvant Intra-tumor Double Immunotherapy for Hepatocellular Carcinoma.

Phase II Study of Neoadjuvant CT-Guided Intra-tumor Double Checkpoint Blockades for Untreated Hepatocellular Carcinoma (HCC) Amenable for Surgical Resection

Source: ClinicalTrials.gov · Last updated 9 Jul 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

This trial is designed to investigate the safety, response rates and survival outcomes of patients with hepatocellular carcinoma by delivery of CTLA4 and PD1 or PDL1 antibodies combination through CT-guided intra-tumor (IT) injection.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
90 (estimated)
First submitted
2 Jul 2024
Start date
1 Jul 2024
Primary completion date
30 Dec 2028
Lead sponsor
Second Affiliated Hospital of Guangzhou Medical University
NCT number
NCT06492408

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 90
  • From 1 Jul 2024 to the primary completion date, 30 Dec 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients participated in clinical trials of equipment or drugs (signed informed consent) within 4 weeks;
  • Any agents which could affect the absorption or pharmacokinetics of the study drugs

Other illness

  • Patients accompany by ascites, hepatic encephalopathy and esophageal and gastric varices bleeding;
  • Any serious accompanying disease, which is expected to have an unknown, impact on the prognosis, include heart disease, inadequately controlled diabetes and psychiatric disorders;
  • Patients accompanied with other tumors or past medical history of malignancy;
  • Allergic to contrast agent;
  • Other conditions that investigator decides not suitable for the trial.

Lab values

  • Patients have poor compliance. A.Impaired clotting test (platelet count \< 60000/mm3, prothrombin activity \< 50%).
    • B.Renal failure / insufficiency requiring hemo-or peritoneal dialysis. C.Known severe atheromatosis. D.Known uncontrolled blood hypertension (\> 160/100 mm/Hg).

Other

  • Pregnant or lactating patients, all patients participating in this trial must adopt appropriate birth control measures during treatment;

Who the study is looking for

  • Histologically or cytologically confirmed previously untreated hepatocellular carcinoma (HCC). If a diagnostic biopsy is available, a pre-treatment biopsy is not required. Patients with a suspected HCC are eligible, but pathology must be confirmed prior to initiating treatment on study.
  • The patient must be a suitable candidate for surgery, in the opinion of the treating physician.
  • Signed and dated written informed consent must be provided by the patient prior to admission to the study in accordance with International Conference on Harmonization-Good Clinical Practice (ICH-GCP) guidelines and to the local legislation.
  • Eastern Cooperative Oncology Group (ECOG) performance status score 0-1
  • Absolute neutrophil count (ANC) \>= 1.5 x 10\^9/L; Hemoglobin \>= 8.0 g/dL; Platelets \>= 100 x 10\^9/L; Total bilirubin =\< 1.5 x upper limit of normal (ULN) (except subjects with Gilbert syndrome who can have total bilirubin \< 3.0 mg/dL); Creatinine =\< 1.5 x ULN or calculated creatinine clearance \>= 50 mL/min using Cockcroft-Gault formula for creatinine clearance calculation OR 24-hour urine creatinine clearance \>= 50 mL/min.
  • Birth control.
  • Willing and able to comply with scheduled visits, treatment plan and laboratory tests.

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The Second Affiliated Hospital of Guangzhou Medical University
Coordinator of this site? Confirm its status
GuanzhouChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.