Combining Chemoradiotherapy With Sintilimab in First-Line ICC
ConditionICC
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorShanghai Zhongshan Hospital
About this trial
To evaluate the effectiveness and safety of GC (gemcitabine + cisplatin) and radiotherapy combined with slulimumab in the treatment of first-line intrahepatic cholangiocarcinoma patients
Eligibility criteria
Qualifiers
Cholangiocarcinoma confirmed by histology/cytology.
The included patients were patients with first-line intrahepatic cholangiocarcinoma treated with GC (gemcitabine + cisplatin) and radiotherapy combined with slulimumab. All lesions are required to be eligible for RT treatment, and at least one of them is evaluable.
ECOG score 0-1 points.
Expected survival time > 3 months.
Disqualifiers
Histology includes components such as hepatocellular carcinoma, fibrolamellar hepatocellular carcinoma, and sarcomatoid hepatocellular carcinoma.
Have a history of hepatic encephalopathy or liver transplantation.
Pleural effusion, ascites, and pericardial effusion with clinical symptoms or needing drainage, only imaging shows a small amount of pleural effusion, ascites, and pericardial effusion and are asymptomatic and can be selected.
People with acute or chronic active hepatitis B or hepatitis C infection, hepatitis B virus (HBV) DNA>2000IU/ml or 104 copies/ml; hepatitis C virus (HCV) RNA>103 copies/ml; hepatitis B Surface antigen (HbsAg) and anti-HCV antibodies were positive at the same time.
Trial design
Treatments tested in this trial
- radiotherapy
- gemcitabine + cisplatin
- slulimumab
Treatment groups
19 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov