Intrahepatic cholangiocarcinoma
Conditions
Interventions
Queue 1 (Darsilim Single Drug):Receive darzalex monotherapy. The recommended dose of darzalex is 150 mg, taken orally daily from D1 to D21. Each cycle lasts for 4 weeks (28 days).
Queue 2 (Dasilei combined with Carlimabucilumab):Receive treatment with darzalex alone or in combination with carlimab. The study treatment is conducted in 4-week (28-day) cycles. The recommended dose
carlimab 200 mg, administered by intravenous drip, given once every 2 weeks.
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. The patient voluntarily participated in this study and signed the informed consent form; 2. Age >= 18 years (calculated from the date of signing the informed consent form), both men and women are eligible; 3. Liver intrahepatic cholangiocarcinoma confirmed by pathological histology or cytological examination, which cannot be surgically removed, relapsed or metastasized, and has progressed or been intolerant to previous at least two systemic treatments (progression within 6 months after neoadjuvant/adoptive therapy can be regarded as failure of first-line treatment); 4. Eastern Cooperative Oncology Group (ECOG) performance status score is 0-1; 5. Expected survival period is more than 3 months; 6. At least one measurable lesion (according to RECIST v1.1 requirements, the measurable lesion on spiral CT or MR scan has a long diameter >= 10 mm or the short diameter of enlarged lymph nodes >= 15 mm; lesions that have progressed or relapsed after local treatment can be regarded as target lesions according to the RECIST v1.1 standard); 7. Basic organ functions are basically normal, without severe abnormalities in blood, heart, lung, liver, kidney, bone marrow and immune deficiency diseases; 8. Recovery from adverse events of previous anti-tumor treatment to baseline, or rated <= 1 level according to the NCI-CTCAE v5.0 of the US National Cancer Institute (excluding alopecia and vitiligo; stable or <= 2 levels of neuropathy induced by previous anti-tumor treatment); 9. Male or fertile female subjects take effective contraceptive measures during the treatment period and within 90 days after the last medication.
Exclusion criteria
Exclusion criteria: 1. Within 5 years or simultaneously having other active malignant tumors other than intrahepatic cholangiocarcinoma. This does not include cured localized tumors such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, prostatic carcinoma in situ, cervical carcinoma in situ, breast carcinoma in situ, etc.; 2. Within 28 days before starting the treatment or within 5 known drug half-lives (whichever is longer), received anti-tumor treatment, including systemic chemotherapy, immunotherapy, hormone therapy, targeted drug therapy or the study drug; 3. Within 2 weeks before the first administration of the study drug, undergone major surgery, chemotherapy, radiotherapy, any investigational drug or other anti-cancer treatment; 4. Previously received CDK4/6 inhibitor drug treatment; 5. Have central nervous system diseases or clinically unstable central nervous system (CNS) metastases of tumors. Clinically stable CNS metastases of tumors refers to confirmed disease stability >= 3 months by MRI or CT scan, and/or controlled by low-dose steroid hormones, anti-epileptic and other symptom relief drugs; 6. Currently have uncontrollable cardiovascular and cerebrovascular diseases or a previous history; 7. Have severe corneal or retinal diseases, including but not limited to: bullous/striped corneal disease, corneal conjunctivitis, corneal abrasion, keratitis/ulcer, etc.; 8. Have a history or current condition of diseases causing changes in calcium and phosphorus homeostasis, such as parathyroid disorders, tumor lysis syndrome, etc.; 9. Have a history of extensive tissue calcification or current evidence of extensive tissue calcification; 10. Have active liver and gallbladder diseases, such as viral hepatitis, liver cirrhosis, untreated or complications after laparoscopic examination or stent placement, including active cholangitis, cholangiocarcinoma, abscess, etc.; Patients with HBV/HCV virus carriers are required to have received antiviral treatment before enrollment, and HBV-DNA/HCV-RNA should decrease by more than 10 times; 11. Unable to swallow pills, have malabsorption syndrome, or have severe gastrointestinal diseases, and the investigator clinically determines that it may affect the absorption, metabolism or elimination of the study drug; 12. Known hereditary or acquired bleeding (such as coagulation dysfunction) or thrombosis tendency, such as hemophilia patients; Currently using or within 10 days before the start of the treatment, have used full-dose oral or injectable anticoagulant drugs or thrombolytic drugs (allowing for preventive use of low-dose aspirin, low-molecular-weight heparin); 13. Have other diseases that are not suitable for immunotherapy, including but not limited to systemic lupus erythematosus, ankylosing spondylitis, etc. immune system diseases, and those requiring long-term continuous oral steroid hormone treatment; 14. Severe, non-healed or open wounds, active ulcers or untreated fractures; 15. Known active HBV infection (HBV DNA > 2000 IU/mL and elevated AST, ALT), active HCV infection (HCV RNA positive and not receiving antiviral treatment), positive HIV history or known acquired immune deficiency syndrome (Acquired Immune Deficiency Syndrome, AIDS); 16. Female subjects are in the pregnancy period or lactation period; 17. The time interval between the last use of a potent CYP3A inhibitor or CYP3A inducer and the first trial medication is less than 5 half-lives, or plan to
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease control ratio,DCR;Objective Response Rate,ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival,OS;Duration of Response,DoR;Dose-limiting toxicity, DLT;Time to Response, TTR;Best overall response,BOR; | — |
Countries
China
Contacts
Public ContactXu Li
Sun Yat-sen University Cancer Center
Outcome results
None listed