Study on the effect of 2 immunotherapy drugs in combination with radioactive glass spheres on the survival in liver cancer
- Conditions
- Patients with hepatocellular cancer, not amenable to curative surgical or ablation treatment.MedDRA version: 21.0Level: LLTClassification code 10036706Term: Primary liver cancer non-resectableSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2020-003925-42-DE
- Lead Sponsor
- Clinics of Munich University LM
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 84
* Histological diagnosis of HCC
* Life expectancy of at least 12 weeks
* Disease which is not amenable to curative surgical or ablation treatment but eligible for TACE with tumor burden < 50% of liver volume
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Preserved liver function, as defined by a Child-Pugh score A and serum Bilirubin <1.5 x institutional upper limit of normal (ULN)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 56
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 28
* Diffuse HCC or presence of vascular invasion or extrahepatic spread (including extrahepatic lymph node affection or metastasis) or more than 7 lesions or at least one lesion = 7 cm
* Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
* Decompensated liver function as defined by any of the following: Clinically meaningful ascites, hepatic encephalopathy or history of hepatic encephalopathy, Child Pugh =7 points. The presence of clinically meaningful ascites is defined as any ascites requiring non-pharmacologic intervention (eg, paracentesis) to maintain symptomatic control, within 6 months prior to the first scheduled dose. Subjects on stable doses of diuretics for ascites for =2 months are eligible
* Uncontrolled pleural effusion or pericardial effusion
* Co-infection of HBV and HCV. Patients with a history of HCV infection but who are negative for HCV RNA by polymerase chain reaction (PCR) will be considered non-infected with HCV.
* Patients on a liver transplantation list
* Prior systemic therapy for HCC (including previous CPI or VEGFi treatment)
* Prior treatment with TACE or SIRT
* Ineligibility for locoregional treatment
* Major gastrointestinal bleeding within 4 weeks prior to inclusion
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: *To assess Objective Response Rate in non-resectable HCC patients treated with first-line systemic treatment in association with SIRT;Secondary Objective: * To evaluate the safety and quality of life of treatment with durvalumab/tremelimumab in combination with SIRT<br>* To evaluate overall survival, progression-free survival, time to progression, and disease control rate of patients treated with durvalumab/tremelimumab in combination with SIRT<br><br>;Primary end point(s): Objective Response Rate ;Timepoint(s) of evaluation of this end point: every 2/3 months during 12 months follow-up
- Secondary Outcome Measures
Name Time Method Secondary end point(s): * Overall survival (calculated form the day of randomization)<br>* Progression-free survival (calculated from the day of randomization); to be evaluated both according to RECIST 1.1 as well as mRECIST<br>* Time to progression (calculated from the day of randomization); to be evaluated both according to RECIST 1.1 as well as mRECIST<br>* Disease control rate at the end of study (12 months FU); to be evaluated both according to RECIST 1.1 as well as mRECIST<br>* Quality of Life: QoL scores from EORTC QLQ-C30 and EORTC QLQ-HCC18 questionnaires <br>* Safety: adverse events <br>* Safety: changes in vital signs (heart rate, blood pressure) <br>* Safety: changes in weight <br>* Safety: shift of laboratory parameters (e.g., from normal to abnormal) ;Timepoint(s) of evaluation of this end point: every 2/3 months during 12 months follow-up