Health TrialsbyHealthPanel

Neoadjuvant Therapy of HAIC（GEMOX） Combined With Adebrelimab and Lenvatinib for Resectable Intrahepatic Cholangiocarcinoma With High-risk Recurrence Factors

ConditionIntrahepatic Cholangiocarcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorThe First Affiliated Hospital with Nanjing Medical University

About this trial

Clinical Study on the efficacy and safety of HAIC（GEMOX）and Lenvatinib combined with Adebrelimab neoadjuvant therapy for resectable Intrahepatic Cholangiocarcinoma with high-risk recurrence factors.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

The patient must sign the informed consent;

Age 18-75 years old, male and female;

ECOG Physical status Score (PS score) 0 or 1;

Patients with ICC who have been pathologically diagnosed (histopathological and/or cytological examination) or clinically diagnosed as having high-risk factors;

Disqualifiers

Pathological diagnosis of hepatocellular carcinoma, mixed hepatocellular carcinoma and other non-cholangiocarcinoma malignant tumor components;

Prior systemic therapy and tumor-related surgical treatment (biliary drainage allowed);Patients who relapse after surgery, have received PD1 antibody, PDL1 antibody or CTLA4 antibody, Lenvatinib, chemotherapy in the past; participated in other clinical trials 30 days before screening

Previous or co-existing malignancies other than adequately treated non-melanin skin cancer, cervical carcinoma in situ and thyroid papillary carcinoma;

Active pulmonary tuberculosis infection. Patients with active pulmonary tuberculosis infection within 1 year prior to enrollment; Had a history of active tuberculosis infection more than 1 year before enrollment, had not received formal anti-tuberculosis therapy or had active tuberculosis;

Trial design

Design model

Single group

Treatments tested in this trial

  • Adebrelimab

    Drug

    1200mg，i.v. , q3w

  • Lenvatinib

    Drug

    8mg,qd

  • Gemcitabine

    Drug

    800 mg/m2，q3w

  • Oxaliplatin

    Drug

    85 mg/m2，q3w

Treatment groups

33 Participants
are divided into 1 treatment group
Group A: Combined treatment groupExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Propotion of treatment completion

Propotion of treatment completion (including neo-adjuvant therapy and surgery)

Time frame
one year

Secondary outcomes

1

Assess safety and tolerability

Assess safety and tolerability of HAIC（GEMOX）and Lenvatinib combined with Adebrelimab neoadjuvant therapy

Time frame
one year
2

OS

Overall survival (OS)

Time frame
one year
3

pCR

Pathological Complete Response (pCR)

Time frame
one year
4

R0 resection rate

The percentage of patients received R0 resection after HAIC（GEMOX）and Lenvatinib combined with Adebrelimab neoadjuvant therapy

Time frame
one year

Other outcomes

Sponsors and contacts

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

The First Affiliated Hospital with Nanjing Medical University

Lead sponsor

Jiangsu Hengrui Pharmaceutical Co., Ltd.

Collaborator

Source ClinicalTrials.gov
Apply now