Status:
UNKNOWN
Neoadjuvant Therapy for Resectable Intrahepatic Cholangiocarcinoma With High Predict Risk of Lymph Node Metastasis
Lead Sponsor:
Eastern Hepatobiliary Surgery Hospital
Conditions:
Intrahepatic Cholangiocarcinoma Recurrent
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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 b...
Detailed Description
Intrahepatic cholangiocarcinoma (ICC) is the second most common liver cancer, and its incidence and mortality have been rising worldwide over the past two decades. Liver resection (LR) remains the onl...
Eligibility Criteria
Inclusion
- 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:
- 1\) 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;
Exclusion
- 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;
- Other factors judged by the investigator that may affect the safety of the subject or the compliance of the trial. Such as serious illnesses (including mental illness) that require combined treatment, serious laboratory abnormalities, other family or social factors, or participating in other clinical trials.
Key Trial Info
Start Date :
December 31 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04523402
Start Date
December 31 2020
End Date
December 31 2023
Last Update
August 21 2020
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