GOT Applied As Neoadjuvant Regimen for Patients of Resectable ICC with High-risk Factors of Recurrence

Launched by ZHEJIANG CANCER HOSPITAL · Sep 24, 2022

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ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with intrahepatic cholangiocarcinoma (ICC), a type of cancer that starts in the bile ducts inside the liver. The researchers want to see if combining two specific treatments—Tislelizumab (an immune therapy) and the GEMOX chemotherapy regimen—can help patients who are at high risk for the cancer coming back after surgery. The goal is to improve the chances of successful surgery and increase survival rates in these patients.

To participate in this trial, individuals must be between 18 and 75 years old and have been diagnosed with ICC that can still be surgically removed. They should not have received other cancer treatments before and must have certain high-risk features, like larger tumors or signs that the cancer may have spread. Participants will receive the new treatment before surgery and will be monitored for how well it works. It’s important for participants to understand that they will need to meet specific health criteria and agree to use effective birth control during the study. This trial is currently looking for volunteers, and those interested should discuss it with their healthcare provider to see if they qualify.

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ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 18-75 yo;
• • 2. Patients of Pathological confirmed intrahepatic cholangiocarcinoma who has never received systemic therapy including chemotherapy, immunotherapy, target therapy and other anti-cancer therapy;
• 3. Patients of resectable ICC with high risk recurrent factors:
• • ①Maximum diameter greater than 5cm or multiple tumors.
• • ②Preoperative CA19-9 greater than 200 Unit(U)/mL
• • ③Tumors invaded adjacent blood vessels
• • ④Preoperative radiology hints suspected regional lymph node metastasis.
• • ⑤Tumor tissues confirmed by CT or MRI, at least one measurable lesion exists according to RECIST v1.1.
• • 4. Eastern Cooperative Oncology Group(ECOG)-Performance status(PS) score is 0 before first drug administration;
• • 5. Child-Pugh classification is class A;
• • 6. Estimated overall survival is greater than 16 weeks;
• 7. The level of organ function meets the criteria and can tolerate surgery before the first treatment. Main organs meet the criteria as below:
• • haemoglobin≥90g/L，Neutrophil count≥1.5×10⁹/L，Platelet count≥100×10⁹/L；Aspartate or alanine aminotransferase≤5 upper limits of normal(ULN），alkaline phosphatase≤2.5 ULN，Serum albumin≥30g/L；serum creatinine\<1.5 ULN；International normalized ratios（INR）≤2 or Prothrombin time（PT）exceed ULN≤6s；Creatinine clearance≥60 mL/min.
• • 8. Male and female subjects with potential fertility had to agree to the use of effective contraceptive methods throughout the study period；
• • 9. Sign an informed consent form agreeing to provide previously preserved specimens of tumor tissue or fresh detection of tumor lesions.
• Exclusion Criteria:
• • 1. Patient with non-intrahepatic cholangiocarcinoma；
• • 2. Anti-cancer therapy or surgery such as radiotherapy, radiofrequency ablation, interventions in 28 days prior to the first dose of the study (except for previous non-tumor-related surgeries and diagnostic biopsies)；
• • 3. Distant metastasis；
• • 4. hepatitis B virus (HBV) DNA\>2000 copies/ml, hepatitis C virus (HCV) RNA\>1000;
• • 5. Long-term glucocorticoid users require long-term systemic hormones (equivalent to \>10 mg Prednisone/day) or any other form of immunosuppressive therapy；
• • 6. Clinically significant bleeding or bleeding tendencies within 3 months prior to enrollment or on thrombolytic or anticoagulant therapy；
• • 7. Patients with complete bowel obstruction and incomplete intestinal obstruction that require treatment, but patients who have been relieved of obstruction by ostomy or stent placement can be enrolled；
• • 8. Active severe clinical infections (\> grade 2, NCI-CTCAE version 5.0), including active TB; Have a history of active TB infection at least 1 year before enrolment, have not received regular anti-tuberculosis (TB) treatment or are still active; active, known or suspected autoimmune disease;
• • 9. Uncontrolled diabetes mellitus (fasting blood glucose ≥10 mmol/L), severe lung disease (eg, acute lung disease, pulmonary fibrosis that affects lung function, interstitial lung disease). except for recovered radiation pneumonia);
• • 10. Clinically significant cardiovascular diseases; With hypertension, antihypertensive drugs cannot be well controlled (systolic blood pressure≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg);
• • 11. Patient who are receiving renal replacement therapy；
• • 12. History of other malignancies in the last 5 years. With the exception of carcinoma of the skin basal cells that have been cured or carcinoma in situ in the cervix;
• • 13. Others situations are not expected to tolerate surgical treatment；
• • 14. People with allergic reactions to any component of the drug under study;
• • 15. There are other unsuitable candidates for clinical trials, such as alcohol dependence, mental illness, pregnancy (or lactation).