RC48-ADC Combinatioed Envolizumab in Locally Advanced or Metastatic Biliary Tract Cancer With Positive HER-2
Study Details
Study Description
Brief Summary
This study was a prospective, single-arm phase II clinical trial to observe and evaluate the efficacy and safety of RC48-ADC combined envafolimab in the first-line treatment of locally advanced or metastatic biliary tract cancer with positive HER-2.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: RC48-ADC plus envafolimab
|
Drug: RC48-ADC
2.5mg/kg, IV, d1, every 2 weeks;
Drug: Envafolimab
200mg, SC, d1, every 2 weeks;
|
Outcome Measures
Primary Outcome Measures
- ORR [6 months]
Objective response rate
Secondary Outcome Measures
- DCR [9 months]
Disease Control Rate
- DOR [12 months]
Duration of Response
- PFS [6 months]
Progression Free Survival
- OS [12 months]
Overall Survival
- AEs [12 months]
Percentage of participants experiencing grade 3-5 adverse events
Other Outcome Measures
- ctDNA [12 months]
circulating tumor DNA
Eligibility Criteria
Criteria
Inclusion Criteria:
-
18 years;
-
ECOG 0-1;
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patients diagnosed by pathological or cytological diagnosis of locally advanced or metastatic biliary tract cancer (include intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, gallbladder and ampullary carcinoma);
-
life expectancy of at least 3 months;
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HER2 IHC 2+ or 3+;
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At least one measurable objective tumor lesion according to RECIST 1.1;
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Not received systemic chemotherapy in the past. Patients who have completed adjuvant therapy or neoadjuvant therapy before the start of the chemotherapy regimen in this trial 6 months ago can be included in this trial.
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satisfactory main organ function (laboratory test must meet the following criteria): hemoglobin (HGB) ≥90g/L, neutrophil count (ANC) ≥1.5×109/L, platelet count (PLT) ≥80×109/L, Serum creatinine (CR) ≤1.5 upper normal limitation (UNL), total bilirubin (TBil) ≤1.5 upper normal limitation (UNL), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 UNL (For patients with liver metastasis, the AST/ALT must be ≤5.0 UNL), left ventricular ejection fraction (LVEF) ≥ 50%;
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Subjects of childbearing potential must use an appropriate method of contraception during the study period and within 120 days after the end of the study, have a negative serum pregnancy test within 7 days prior to study enrollment, and must be non-lactating subjects;
Exclusion Criteria:
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Previously received drug therapy against PD-1/PD-L1 inhibitor and other Antibody conjugate drug (Such as T-DM1 and DS8201);
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Allergic to the active ingredients or excipients of the study drug;
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biliary obstruction were excluded. Unless blockage is treated locally, such as endoscopic stenting, percutaneous hepatic drainage, etc., total bilirubin is reduced below the upper limit of 1.5 UNL;
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A history of malignancies other than biliary tract malignancies (other than cured carcinoma in situ of the cervix or basal cell carcinoma of the skin and other malignancies cured for 5 years);
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Received major surgical treatment, incisional biopsy, or significant traumatic injury within 28 days prior to the start of study treatment; or had a long-term unhealed wound or fracture;
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Unsuitable for the study or other chemotherapy determined by investigator.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Jiangsu Cancer Institute & Hospital
Investigators
- Study Chair: Liangjun Zhu, Jiangsu Cancer Institute & Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2022-030