Neoadjuvant Therapy for Resectable Intrahepatic Cholangiocarcinoma With High Predict Risk of Lymph Node Metastasis

NCT04523402 | Unknown Phase 2

• 1 other identifier: EHBHKY2020-K-027
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

A randomized controlled, open label, phase II clinical trial is designed to target patients with resectable intrahepatic cholangiocarcinoma (ICC) with high risk of lymph node metastasis as evaluated by our previously established radiomics model, which has low postoperative recurrence-free survival. In this study, we aim to compare the prognosis of ICC patients who undergo liver resection (LR) following preoperative oxaliplatin and gemcitabine (GEMOX) neoadjuvant therapy (experimental arm) versus LR alone (control arm).

Conditions

Intrahepatic Cholangiocarcinoma Recurrent

Keywords

Intrahepatic Cholangiocarcinoma; Neoadjuvant chemotherapy

Outcome Measures

Primary Outcomes (1)

• Event-free survival

  The time period from randomization to the occurrence of the following events: disease progression prevents liver resection; local or distant recurrence; second primary tumor; death due to various causes.

  24 months

Secondary Outcomes (3)

• Overall survival

  36 months

• Objective response rate

  4 months

• Adverse events

  6 months

Study Arms (2)

Neoadjuvant chemotherapy following liver section

EXPERIMENTAL

1\. GEMOX chemotherapy: 1. It is performed within one week after the identification of ICC; 2. Day1 Oxaliplatin 85mg/m2 + gemcitabine 1g/m2, Day 8 gemcitabine 1g/m2; 3. Three weeks is a course of treatment; 4. A total of 3 courses. 2\. Liver resection: It is performed 1 month after chemotherapy

Drug: Neoadjuvant chemotherapy

Liver resection

NO INTERVENTION

Liver resection: It is performed within one week after the identification of ICC.

Interventions

Neoadjuvant chemotherapy DRUG

Neoadjuvant chemotherapy with GEMOX regimen before liver resection

Also known as: Preoperative chemotherapy

Neoadjuvant chemotherapy following liver section

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sign written informed consent;
• Male or female patients aged 18-70;
• Eastern Cooperative Oncology Group (ECOG) score 0 points, Child-Pugh rating A;
• Clinically diagnosed as ICC as a potential entry, the neochemotherapy plus liver resection group must be histopathologically diagnosed as ICC before chemotherapy, and the liver resection alone group must be pathologically confirmed as intrahepatic cholangiocarcinoma after surgery;
• Resectable ICC patients with high risk of LN metastasis (Probability of LN metastasis ≥50% as evaluated by radiomics model);
• The subject has at least 1 measurable liver disease (according to Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1);
• For women who are not breastfeeding or pregnant, use contraception during treatment or 3 months after the end of treatment.
• The functional indicators of important organs meet the following requirements:
• \) Neutrophils≥1.5\*109/L; platelets≥90\*109/L; hemoglobin≥9g/dl; serum albumin≥3.5g/dl; 2) Coagulation function: International standardization (prothrombin time) ratio (INR) \<1.2; 3) Thyroxine (T3 and T4) do not exceed the normal upper and lower limits by 2 times; 4) Bilirubin ≤ 1.5 times the upper limit of normal; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 times the upper limit of normal; 5) Serum creatinine ≤ 1.5 times the upper limit of normal, creatinine clearance ≥ 60ml/min;

You may not qualify if:

• Pathological diagnosis of hepatocellular carcinoma, mixed hepatocellular carcinoma and other non-biliary cell carcinoma malignant tumor components;
• Patients who have recurrent ICC after surgery, or have chemotherapy in the past;
• Past or simultaneous suffering from other malignant tumors, except for fully treated non-melanoma skin cancer, cervical carcinoma in situ and thyroid papillary carcinoma;
• Active tuberculosis infection. Patients with active tuberculosis infection within 1 year before enrollment; a history of active tuberculosis infection more than 1 year before enrollment, no formal anti-tuberculosis treatment or tuberculosis is still active;
• Suffer from active, known or suspected autoimmune diseases. Subjects with hypothyroidism who only need hormone replacement therapy and skin diseases without systemic therapy can be selected;
• Past interstitial lung disease, or (non-infectious) pneumonia and need oral or intravenous steroid therapy;
• Long-term use of systemic hormones (dose equivalent to \>10mg prednisone/day) or any other form of immunosuppressive therapy is required. Subjects using inhaled or topical corticosteroids can be selected;
• Active infections that require systemic treatment;
• Human immunodeficiency virus (human immunodeficiency virus \[HIV\], HIV1/2 antibody) positive;
• A history of psychotropic drug abuse, alcohol or drug abuse;
• Significant clinically significant bleeding symptoms or a clear tendency to appear within 3 months before enrollment;
• Suspected of being allergic to study drugs;
• Suffer from hypertension, and cannot be well controlled by antihypertensive medication (systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg);
• After antiviral therapy, hepatitis B virus (HBV)-DNA\>104 copies/ml, hepatitis C virus (HCV)-RNA\>1000;
• Accompanied by ascites, hepatic encephalopathy, Gilbert syndrome, sclerosing cholangitis, etc. Combined with insufficiency of other organs, it is expected that they cannot accept general anesthesia or hepatectomy;

Sponsors & Collaborators

• Eastern Hepatobiliary Surgery Hospital: lead

MeSH Terms

Conditions

Cholangiocarcinoma

Interventions

Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics

Central Study Contacts

Jun Li, M.D.

CONTACT

18930560396; lijundfgd1@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: August 19, 2020
• First Posted: August 21, 2020
• Study Start: December 31, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2023
• Last Updated: August 21, 2020

Record last verified: 2020-08