DEB-TACE Combined With Apatinib and PD-1 for the Treatment of Intrahepatic Cholangiocarcinoma

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Brief Title

DEB-TACE Combined With Apatinib and PD-1 for the Treatment of Intrahepatic Cholangiocarcinoma

Official Title

Drug-eluting Beads Transarterial Chemoembolization Combined With Apatinib and PD-1 Antibody for the Treatment of Intrahepatic Cholangiocarcinoma That Has Progressed After Standard First-line Chemotherapy

Brief Summary

      Intrahepatic cholangiocarcinoma (ICC) is a malignant tumor of biliary epithelial cells that
      originates from the branches of the intrahepatic bile duct at the second level and above. Its
      incidence accounts for about 15%-20% of primary liver malignancies, showing a gradually
      increasing trend. Surgical resection is currently the main method for the treatment of ICC.
      However, most (60% -70%) patients are diagnosed at the advanced stage. Gemcitabine plus
      cisplatin is the standard first-line incurable resection recommended in international and
      domestic guidelines. There is not a standard second-line treatment that has progressed after
      standard first-line chemotherapy.

      The clinical benefits of immune therapies for HCC are emerging. Early clinical data already
      show the safety of immune checkpoint inhibition. This study is to analyze the safety and
      efficacy of drug-eluting beads transarterial chemoembolization combined with apatinib and
      carrelizumab injection in the treatment of ICC that has progressed after standard first-line
      chemotherapy.

      Patients who were aged 18 to 80 years with a histological or cytological diagnosis of
      ICC,locally advanced or multiple liver metastases, including progression after gemcitabine
      chemotherapy, will be enrolled in this trial.
    

Detailed Description

      This study is a single arm, single center, open label study. It is estimated that 20 patients
      with intrahepatic cholangiocarcinoma which progressed after treatment with standard
      first-line chemotherapy in patients will be enrolled. The trial period of subjects includes
      screening period, treatment period and follow-up period.

      The drug treatment was 200 mg of PD-1 monoclonal antibody, intravenous infusion on the first
      day, every 21 days as a treatment cycle; mesylate apatinib, 250 mg, oral once a day,
      continuous oral; DEB-TACE, the CalliSpheres + gemcitabine (800mg) and oxaliplatin were
      injected into the hepatic artery by routine procedure, repeated every 4-6 weeks, and
      administered for according to the physician in charge, DEB-TACE treatment cycles. Treatment
      continues until the disease progresses, intolerable toxicity occurs, new anti-tumor treatment
      is started, informed consent is withdrawn, follow-up is lost, death occurs or treatment
      termination is required。 Screening will be performed between days - 21 and - 4. Informed
      consent was signed up to 4 weeks prior to the first day of cycle 1 before any screening
      procedure or evaluation was performed and the trial was fully explained to each subject.

      Baseline evaluation results must be collected prior to the first trial drug administration
      (day 1 of cycle 1). Baseline assessments may be performed between days - 3 and - 1 or on day
      1 of cycle 1. If performed within 3 days before the first day of cycle 1, the screening
      results can be used as baseline results.

      The tumor imaging was evaluated every 4-6 weeks since the first administration, and every 12
      weeks (± 7 days) after 24 weeks. If there are clinical indications for disease progression,
      tumor evaluation is more frequent. In the event of disease progression, unacceptable
      toxicity, the subject's request to discontinue the trial or the subject's withdrawal of
      consent, the subject will discontinue the trial treatment.

      When the trial treatment is stopped, the treatment visit shall be stopped within 7 days after
      the treatment is stopped in order to stop the treatment examination.

      After the end of the treatment period (up to 2 years), subjects who can benefit from the
      study drug will continue to study the treatment of the drug until disease progression,
      intolerable adverse reactions, withdrawal of intensive care facility (ICF), other anti-tumor
      treatment, loss of follow-up, death or termination of the study.

      After the occurrence of a clinical event, if it is judged by the investigators that it should
      be attributed to the progress of the disease and it is unlikely to recover even if the
      patient continues to receive treatment, it can be evaluated as clinical deterioration. It is
      up to the investigator to discuss and decide whether to continue or stop the treatment for
      the subject and record in the study file.

      At the end of the study, subjects who are still under study treatment can continue to receive
      treatment through another extended study or other forms at the discretion of the investigator
      if they are stable or relieved in the efficacy evaluation and can tolerate the adverse
      reactions.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

objective response rate (ORR)

Secondary Outcome

 overall survival (OS)

Condition

Intrahepatic Cholangiocarcinoma

Intervention

DEB-TACE combined with apatinib and PD-1 antibody

Study Arms / Comparison Groups

 DEB-TACE combined with apatinib and PD-1 antibody
Description:  The participants will receive the combined treatment of local therapy (DEB-TACE, oxaliplatin and gemcitabine), antiangiogenic therapy (apatinib), and immunotherapy (PD-1 antibody)

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Combination Product

Estimated Enrollment

20

Start Date

May 1, 2021

Completion Date

April 30, 2024

Primary Completion Date

April 30, 2023

Eligibility Criteria

        Inclusion Criteria:

          1. The diagnosis of ICC

          2. Patients must have at least one tumor lesion that can be accurately measured according
             to mRECIST criteria.

          3. Stand first-line chemotherapy resistance.

          4. Performance status (PS) ≤ 2 (ECOG scale).

          5. Child Pugh score ≤ 7.

          6. Not amendable to surgical resection ,local ablative therapy and any other cured
             treatment.

          7. Platelet count ≥ 50,000/μL Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/L Serum
             albumin ≥ 32 g/L ASL and AST ≤ 6 x upper limit of normal Serum creatinine ≤ 1.5 x
             upper limit of normal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil
             count (ANC) >1,500/mm3

          8. Sign the written informed consent, and be able to follow the visit and relevant
             procedures specified in the plan

        Exclusion Criteria:

          1. Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or
             hepatic encephalopathy

          2. Known history of HIV

          3. History of organ allograft

          4. Known or suspected allergy to the investigational agents or any agent given in
             association with this trial.

          5. Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy

          6. Evidence of bleeding diathesis.

          7. Patients with clinically significant gastrointestinal bleeding within 30 days prior to
             study entry.

          8. Known central nervous system tumors including metastatic brain disease

          9. Tumor burden≥70%, diffuse liver cancer or tumor is not suitable for mRECIST standard
             evaluation.

         10. Received local treatment (ablation therapy), surgery resection and radiotherapy for
             ICC before the first administration.

         11. Tumor thrombus of main portal vein, or involving superior mesenteric vein at the same
             time.
      

Gender

All

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

, +8613708010123, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT04834674

Organization ID

GHX


Responsible Party

Principal Investigator

Study Sponsor

Sichuan Cancer Hospital and Research Institute


Study Sponsor

, , 


Verification Date

April 2021