Skip to content

Combination of percutaneous fiber-optic intratumoral photodynamic therapy with immune checkpoint inhibitor in the treatment of hepatocellular carcinoma

Combination of percutaneous fiber-optic intratumoral photodynamic therapy with immune checkpoint inhibitor in the treatment of hepatocellular carcinoma

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100053067
Enrollment
Unknown
Registered
2021-11-10
Start date
2021-11-16
Completion date
Unknown
Last updated
2022-09-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular carcinoma (HCC)

Interventions

Experimental group:Photodynamic interventional therapy

Sponsors

The Second Affiliated Hospital of Harbin Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Patients signed informed consent and underwent relevant treatment and examination; 2.Inclusion criteria of ICIs immunotherapy combined with targeted therapy: (1)Advanced HCC diagnosed by pathology; (2)BCLC phase B (not suitable for TACE) or phase C; (3)Child Pugh class A; (4)ECOG PS 0-1; (5)At least one measurable lesion (mRECIST standard). 3.Photodynamic therapy inclusion criteria: (1)Liver function is in the compensatory stage, non diffuse large and small liver cancer; (2)The risk of local treatment at the location of tumor is high; (3)Tumor lesions are extensive, which is not suitable for local treatment such as surgery, radiofrequency ablation and interventional therapy; (4)Accompanied by chronic heart, lung and kidney diseases, but not in the acute stage; (5)Patients who volunteered and accepted photodynamic therapy; (6)Optical fiber can reach the treatment site.

Exclusion criteria

Exclusion criteria: 1.Patients with diffuse hepatocellular carcinoma; 2.Alanine aminotransferase (ALT) 100-150u, bilirubin 5 times higher than normal; 3.Portal vein branch tumor thrombus, intrahepatic small bile duct tumor thrombus, early distant metastasis, severe yellow skin, ALT > 150u, albumin lower than 25g/L, medium or above uncorrectable ascites, gastrointestinal bleeding; 4.Patients with severe systemic acute infection, coagulation mechanism disorder or other serious systemic diseases; 5.Patients with a history of severe photoallergy; 6.Complicated with severe hypertension or cardiogenic diseases; 7.Combined with severe cachexia, it is estimated that the local injury after PDT is difficult to repair or the survival time is less than two months; 8.Some individual contraindications, such as esophageal cancer with mediastinal fistula.

Design outcomes

Primary

MeasureTime frame
Efficacy and safety;Imaging: enhanced liver computed tomography/magnetic resonance imaging;Efficacy evaluation criteria for solid tumors;Serum T cell subsets were detected;Serum complement detection;

Secondary

MeasureTime frame
Optimum time window;Overall survival in patients with liver cancer;Evaluation of patient quality of life;

Countries

China

Contacts

Public ContactLi Li

The Second Affiliated Hospital of Harbin Medical University

8028522@qq.com+86 15804626219

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026