Biliary tract cancer (intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, gallbladder cancer)
Conditions
Interventions
Experimental group:Inetetamab and Pyrotinib Combined with Gemcitabine and Cisplatin
Sponsors
Beijing Chao-Yang Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Male or female >=18 years of age; 2. Histopathologically confirmed HER2-expressing cholangiocarcinoma met the following criteria: HER2-expressing patients were defined as either HER2 + by immunohistochemical staining (IHC) and negative by fluorescence in situ hybridization (FISH), or HER21 + by IHC and ERBB2 amplification by NGS. Tumor stage: Recurrent or metastatic cholangiocarcinoma; Patients with local recurrence need to be confirmed by the investigator that radical surgical resection is not possible. 3. The ECOG score is 0 to 1; 4. No previous treatment with anti-HER2 drugs; 5. At the recurrence/metastasis stage, the patient did not receive any systematic antitumor therapy; 6. Patients with disease recurrence > 6 months after radical surgery; Patients who received adjuvant therapy (chemotherapy and/or radiotherapy) after surgery should be > 6 months after completion of adjuvant therapy; 7. The presence of at least one measurable lesion according to RECIST version 1.1; Lesions located within the field of previous radiotherapy may be considered measurable if progression is demonstrated; 8. Functional level of major organs must be required (no blood transfusion within 2 weeks prior to screening, no use of leukocytotropic or platelet-enhancing drugs); 9. Expected survival >=3 months; 10. Volunteer to participate in this study, sign informed consent, have good compliance and willing to cooperate with follow-up;
Exclusion criteria
Exclusion criteria: 1. Known allergic history of the drug components of this protocol; 2. Previously received anti-HER2 monoclonal antibody therapy, including but not limited to trastuzumab, pertuzumab, etc; 3. There's central nervous system metastasis; 4. Other malignancies developed within 5 years (other than adequately treated cervical carcinoma in situ or skin squamous cell carcinoma, or skin basal cell carcinoma under control); 5. Pregnant and lactating women; 6. Had undergone major surgical procedures or significant trauma within 4 weeks prior to randomization, or were expected to undergo major surgical treatment; 7. For other reasons, the researchers considered it inappropriate to participate in this study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression free survival, PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate, ORR;disease control rate, DCR;Overall Survival, OS;Quality of life;safety; | — |
Countries
China
Contacts
Public ContactYang Ge
Beijing Chao-Yang Hospital, Capital Medical University
Outcome results
None listed