Hepatic Arterial Infusion Chemotherapy (HAIC) Combined With Durvalumab and Lenvatinib in Patients With Locally Advanced or Metastatic Intrahepatic Cholangiocarcinoma: a Phase 2 Study(HAIC-quad Trial)
1. Histologically confirmed intrahepatic cholangiocarcinoma, with a preliminary diagnosis of unresectable or metastatic disease and no previous systemic treatment.
Anatomical factors: ① Patients with invasion of the portal vein, hepatic vein or main bile duct, who cannot undergo resection and reconstruction; ② Patients with decompensated cirrhosis or severe portal hypertension, and the residual liver FLR does not meet the safe liver resection decision-making system Biological factors: ① Multiple tumors in the left and right livers; ② Metastasis to distant lymph nodes such as the para-aorta or distant organ metastasis
2. Disease recurrence \> 6 months after radical surgery; if adjuvant therapy is given after surgery, patients \> 6 months after completion of adjuvant therapy (chemotherapy and/or radiotherapy) are eligible for inclusion.
3. WHO/ECOG PS of 0 or 1
4. There was at least 1 target lesion (TL) that met the RECIST 1.1 criteria
You may not be if
1. Patients who have received systemic treatment in the past.
2. Patients with severe liver dysfunction (Child-Pugh C grade), or significant jaundice, hepatic encephalopathy, refractory ascites, or hepatorenal syndrome.
3. Patients with severe and uncorrectable coagulation dysfunction.
4. Patients with active hepatitis or severe infection who cannot be treated simultaneously.
5. Patients with cachexia or multiple organ failure.
Clareo Health | Hepatic Arterial Infusion Chemotherapy (HAIC) Combined With Durvalumab and Lenvatinib in Patients With Locally Advanced or Metastatic Intrahepatic Cholangiocarcinoma: a Phase 2 Study(HAIC-quad Trial)
