Treatment for advanced biliary tract cancer with HER2 expression
A Phase II Clinical Study of SHR-A1811 in Patients With HER2-expressing/Amplified, Locally Advanced, Unresectable or Metastatic Biliary Tract Cancer (BTC) Who Have Previously Failed First or Second-line Systemic Therapy
This study is testing a new drug called SHR-A1811 to see if it can help people with advanced biliary tract cancer that has not responded to other treatments.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 65 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Jiangsu HengRui Medicine Co., Ltd. Industry-sponsored |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06413745 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy and safety of SHR-A1811 in patients suffering from locally advanced unresectable or recurrent metastatic biliary tract cancer that expresses or amplifies HER2. Participants must have previously failed first-line or second-line systemic treatments. The study aims to determine how well this new treatment works in this specific patient population. Patients will be monitored for both the effectiveness of the drug and any potential side effects.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with HER2 expression or amplification in biliary tract cancer who have not responded to prior systemic therapies.
Not a fit: Patients with brain metastasis or those who have received recent anti-tumor treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced biliary tract cancer who have limited treatment choices.
How similar studies have performed: While there have been studies targeting HER2 in other cancers, this specific approach in biliary tract cancer is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 18-75 years old ( including both ends ), male or female ; 2. ECOG-PS score : 0 or 1; 3. Expected survival ≥ 12 weeks; 4. Subjects with locally advanced or recurrent metastatic biliary tract cancer diagnosed by histopathology or cytology are not suitable for surgical resection, transplantation or ablation; 5. Subjects who failed or intolerance after systemic chemotherapies; 6. According to the RECIST v1.1 standard, the subjects had at least one measurable lesion； 7. The main organ function is normal, in line with the program requirements ; 8. If the patient has active hepatitis B virus ( HBV ) infection : HBV-DNA must be \< 500 IU / mL； 9. Consent to contraception. Exclusion Criteria: 1. Received anti-tumor treatment such as chemotherapy, radiotherapy, immunotherapy, biotherapy or other clinical research drugs within 4 weeks before the first administration; 2. Subjects with a history or evidence of brain metastasis or meningeal metastasis ; 3. With acute or chronic uncontrolled pancreatitis or Child-Pugh liver function grade C ; 4. Severe trauma or major surgery was performed within 4 weeks before the first administration; 5. To study the severe heart disease within 6 months before the first administration ; 6. Patients with clinical symptoms and uncontrolled moderate and above pleural effusion, ascites or pericardial effusion, requiring therapeutic puncture drainage ; 7. Severe infection symptoms occurred within 2 weeks before the first administration; 8. Known hereditary or acquired bleeding and thrombotic tendency ; 9. Congenital or acquired immune defects; 10. The subjects had severe and uncontrollable concomitant diseases; 11. Cerebral infarction, pulmonary embolism or deep vein thrombosis occurred within 6 months before the first administration of the study;
Where this trial is running
Shanghai, Shanghai Municipality
- Zhongshan Hospital，Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Shiwei Sun
- Email: Shiwei.sun@hengrui.com
- Phone: +86 18036618554
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.