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)

Inclusion Criteria:

1. Histologically confirmed intrahepatic cholangiocarcinoma, with a preliminarydiagnosis of unresectable or metastatic disease and no previous systemic treatment. Anatomical factors: ① Patients with invasion of the portal vein, hepatic vein ormain bile duct, who cannot undergo resection and reconstruction; ② Patients withdecompensated cirrhosis or severe portal hypertension, and the residual liver FLRdoes not meet the safe liver resection decision-making system Biological factors: ①Multiple tumors in the left and right livers; ② Metastasis to distant lymph nodessuch as the para-aorta or distant organ metastasis

2. Disease recurrence > 6 months after radical surgery; if adjuvant therapy is givenafter 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

Exclusion Criteria:

1. Patients who have received systemic treatment in the past.

2. Patients with severe liver dysfunction (Child-Pugh C grade), or significantjaundice, 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 treatedsimultaneously.

5. Patients with cachexia or multiple organ failure.