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This is a phase 2 clinical study,to explore the efficacy and safety of Disitamab Vedotin in patients with locally advanced or metastatic pancreatic cancer expressing HER2.
63 patients with locally advanced or metastatic pancreatic cancer will participate in this study. HER2 expression in locally advanced or metastatic pancreatic cancer patients is defined as the expression of HER2 in tumor tissues detected by immunohistochemistry (IHC) as IHC 1+, 2+, or 3+. The arm 1 recruits 43 patients and the arm 2 recruits 20 patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Disitamab Vedotin combined with Gemcitabine,2L | Experimental | Disitamab Vedotin 2.5 mg/kg,iv,Q3W; Gemcitabine 1g/m2,iv,d1, d8 Q3W; Disitamab Vedotin+Gemcitabine is used as second-line treatment for HER2-expressive patients who have failed first-line gemcitabine-free regimen or are intolerant to gemcitabine-containing regimen. |
|
| Disitamab Vedotin,3L | Experimental | Disitamab Vedotin 2.5 mg/kg,iv,Q3W; Disitamab Vedotin in HER2-expressive patients who have failed at second-line standard treatment or are intolerant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Disitamab Vedotin | Drug | Disitamab Vedotin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Object Response Rate, ORR | Defined as the percentage of participants with a complete response (CR) or partial response (PR) | up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Control Rate, DCR | Defined as the proportion of participants who have a complete response (CR), partial response (PR) or standard disease (SD) as assessed by investigator according to RECIST 1.1 | up to 12 months |
| Progress Free Survival, PFS |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dong sheng Zhang, PhD | Contact | 86-020-87342479 | zhangdsh@sysucc.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Dong sheng Zhang, PhD | Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China | Principal Investigator |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| C000722994 | disitamab vedotin |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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| Gemcitabine | Drug | Gemcitabine |
|
Defined as time from randomization until progression per RECIST 1.1 as assessed by investigator, or death due to any cause.
| up to 12 months |
| Over Survival, OS | Defined as time from randomization until the date of death due to any cause. | up to 12 months |
| Adverse Events (AE) | NCI-CTCAE v5.0 | up to 12 months |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |