Camrelizumab in Combination With Apatinib in Advanced ICC: A Single-arm Phase II Study

Inclusion Criteria:

• Histopathologically confirmed advanced ICC, or combined hepatocellular andcholangiocarcinoma (cHCC-CC, composition of cholangiocarcinoma >50%). nonresectable ormetastatic cholangiocarcinoma and are not eligible for curative resection,transplantation, or ablative therapies.
• Have at least one measurable lesion (in accordance with RECIST v1.1); the measurablelesion has a long diameter ≥ 10 mm or lymphadenopathy has a short diameter ≥ 15 mm inspiral CT scan.
• Child-Pugh Class: Grade A
• ECOG-PS score 0 or 1
• Life Expectancy of at least 3 months
• Have the required screening laboratory values

Exclusion Criteria:

• Extrahepatic cholangiocarcinoma (EHCC) and primary liver cancer. other activemalignant tumors except for ICC within 3 years or simultaneously. Cured localizedtumor, for example, basal cell carcinoma of skin, squamous cell carcinoma of skin,superficial bladder cancer, carcinoma in situ of prostate, carcinoma in situs ofcervix, breast cancer in situ may be enrolled.
• Any active autoimmune disease or history of autoimmune disease and expected recurrence (including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis,enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism [subjects that can be controlled with hormone replacement therapy only can beenrolled]); subjects with skin diseases that does no need systemic treatment, forexample, leukoderma, psoriasis, alopecia, those with controlled type I diabetes byinsulin or those with asthma that has been completely resolved in childhood and withno need of any intervention can be enrolled; while subjects with asthma who needbronchodilator for medical intervention cannot be enrolled;
• Use of strong CYP3A4/CYP2C19 inducers, including rifampicin (and its analogues) andSt. John's Wort, or strong CYP3A4/CYP2C19 inhibitors within two weeks prior to signinginformed consent form.
• Previous treatment with other immune checkpoint inhibitors (include PD-1 antibody orother immunotherapy against PD-1/PD-L1), or previous use of Apatinib.
• Known history of serious allergy to any monoclonal antibody or Apatinib.
• Inability or unwilling to swallow tablets, malabsorption syndrome or any conditionaffecting gastrointestinal absorption.
• Previous or current presence of metastasis to central nervous system.
• Severe infection within 4 weeks prior to the start of study treatment, including butnot limited to hospitalization for infection, bacteremia or complications of severepneumonia; oral or intravenous therapeutic antibiotics within two weeks prior to thestart of study treatment (for example, subjects who are given with preventiveantibiotics for prevention of urinary tract infection or exacerbation of chronicobstructive pulmonary disease are eligible for participation in the study);
• Other factors that may affect the study results or lead to forced termination of thestudy early as judged by investigators, such as alcoholism, drug abuse, other seriousdiseases (including mental disorders) requiring concomitant therapy, with seriouslaboratory examination abnormality, with family or social factors, that may affectsubject's safety.