Study of TQB2450 Combined With Anlotinib in Subjects With Advanced Cholangiocarcinoma

Inclusion Criteria:

1.18 and 75 years; Eastern Cooperative Oncology Group (ECOG) performance status score of 0or 1; Life expectancy ≥ 3 months.

2. Histologically or cytologically confirmed inoperable or metastatic cholangiocarcinoma.

3. Providing tumor specimen obtained by biopsy or surgical sample within 2 years.

4. At least one measurable lesion. 5. Has failed with standard first-line chemotherapy orwere not suitable for standard first-line chemotherapy.

6.The main organs function are normally. 7. Male or female subjects should agree to use anadequate method of contraception starting with the first dose of study therapy through 6months after the last dose of study (such as intrauterine devices , contraceptives orcondoms) ；No pregnant or breastfeeding women, and a negative pregnancy test are receivedwithin 7 days before the randomization.

8.Understood and signed an informed consent form.

Exclusion Criteria:

1. Prior therapy with VEGFR-target TKI included anlotinib or an anti-programmed celldeath (PD)-1, anti-PD-L1, anti-PD-L2, anti-tumor necrosis factor CD137, oranti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody ,or any otherantibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.

2. Hypersensitivity to recombinant humanized anti-PD-1 monoclonal Abm or its components.

3. Has diagnosed and/or treated additional malignancy within 5 years prior torandomization. Exceptions include cured basal cell carcinoma of skin and carcinoma insitu of cervix.

4. Has any active autoimmune disease or a history of autoimmune disease.

5. Has immunosuppressive therapy with systemic or absorbable topical hormone therapy andreplacement therapy for hypothyroidism with normal thyroid function within 2 weeksbefore the first dose.

6. Has multiple factors affecting oral medication.

7. Has uncontrollable pleural effusion, pericardial effusion, or ascites requiringrecurrent drainage procedures.

8. Has any signs of bleeding or a history of physical illness.

9. Has uncontrollable symptoms of brain metastasis, spinal cord compression, cancerousmeningitis during screening within 8 weeks before first dose.

10. Has received chemotherapy, surgery, radiotherapy, the last treatment from the firstdose less than 4 weeks, or oral targeted drugs for less than 5 half-lives, or oralfluorouracil pyridine drugs for less than 14 days, mitomycin C and nitrosourea forless than 6 weeks.

11. Has any serious and / or uncontrolled disease.

12. Has vaccinated with vaccines or attenuated vaccines, or received granulocyte colonystimulating factor(G -CSF)，or Granulocyte macrophage colony stimulating factor (GM-CSF) within 4 weeks prior to first dose.

13. According to the judgement of the researchers, there are other factors that may leadto the termination of the study. For example, other serious diseases including mentaldisorders need to be treated together, serious laboratory abnormalities, accompaniedby family or social factors, which will affect the safety of the subjects, or thecollection of data and samples.