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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

This trial does not accept healthy volunteers

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 population

First-line patients with intrahepatic cholangiocarcinoma

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • radiotherapy

    Radiation

    radiotherapy

  • gemcitabine + cisplatin

    Drug

    Gemcitabine 1000mg/m² intravenous infusion over 30 minutes, cisplatin 25mg/m² intravenous infusion, on day 1 and day 8, every 3 weeks.

  • slulimumab

    Drug

    Slulimumab, 4.5mg/kg intravenous infusion, Q3W

Treatment groups

19 Participants
are divided into 1 treatment group
Group A: GC (gemcitabine + cisplatin) + radiotherapy + slulimumab Group3 interventions

Trial outcomes

Primary outcomes

1

Progression-free survival(PFS)

The time from the date of first treatment to disease progression or death, whichever occurs first.

Time frame
2 years

Secondary outcomes

1

Time-To-Progression

The time from the date of first treatment to any recorded imaging tumor progression.

Time frame
2 years
2

Objective Response Rate

The use of RECIST version 1.1 standards to evaluate the objective efficacy of tumors, including cases of CR and PR.

Time frame
2 years
3

Disease Control Rate

The percentage of CR, PR and SD (≥4 weeks) cases among patients whose efficacy can be evaluated.

Time frame
2 years
4

Incidence of Adverse events

AEs and SAEs, drug-related AEs and SAEs.

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Zhongshan Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: