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| Name | Class |
|---|---|
| Jiangsu HengRui Medicine Co., Ltd. | INDUSTRY |
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To evaluate the safety and efficacy of HRS-4642 in Combination With AG and Adebrelimab for Neoadjuvant and Adjuvant Treatment of Pancreatic Cancer
This study is an open, single center, exploratory clinical trial aimed at evaluating the safety and efficacy of HRS-4642 in combination with gemcitabine and albumin-bound paclitaxel and Adebrelimab for neoadjuvant and adjuvant treatment of pancreatic cancer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HRS-4642+AG +Adebrelimab | Experimental | HRS-4642 in Combination With Gemcitabine and Albumin-bound Paclitaxel and Adebrelimab will be administrated per dose level in which the patients are assigned. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-4642+AG +Adebrelimab | Drug | HRS-4642 in Combination With Gemcitabine and Albumin-bound Paclitaxel and Adebrelimab will be administrated per dose level in which the patients are assigned. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events (AEs) | AEs are assessed by NCI-CTCAE v5.0 | From the first drug administration to within 30 days for the last dose |
| Objective Response Rate (ORR) | Evaluated by RECIST v1.1 | Up to approximately 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| pathologic complete response (pCR) | Number of subjects achieving pCR as a percentage of subjects | At the time of surgery |
| Overall survival (OS) | Time from the date of enrollment to data of death from any cause, or date of lost follow-up, whichever comes first, and otherwise censored at time last known alive. |
| Measure | Description | Time Frame |
|---|---|---|
| CA19-9 response rate | Up to approximately 6 months |
Inclusion Criteria:
Exclusion Criteria:
Previously received any anti-tumor therapy;
the presence of distant metastatic lesions diagnosed by imaging;
Known hypersensitivity to the study drug or any of its components;
previous or concurrent other malignant tumors;
Participation in a clinical trial of any drug or medical device within 4 weeks prior to the first dose;
Received live and attenuated vaccines within 4 weeks prior to the first dose of the investigational drug;
previous allogeneic hematopoietic stem cell transplantation or organ transplantation;
Patients with severe cardiovascular arterial thromboembolism (e.g., myocardial infarction, unstable angina, stroke), NYHA class 2 or greater cardiac insufficiency, and clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention;
with interstitial lung disease, non-infectious pneumonia or severe and uncontrolled medical illness, acute infections, recent history of major surgery (within 28 days or not yet recovered from side effects);
with congenital or acquired immunodeficiencies such as human immunodeficiency virus (HIV) infection, active hepatitis B (positive hepatitis B virus surface antigen [HBsAg] test result at screening together with an HBVDNA test value of ≥10,000 copies/ml [2000 IU/ ml]), active hepatitis C (hepatitis C virus antigen [HCV-antibodies] at screening), or active hepatitis C (hepatitis C virus antitoxin [HCVantibodies] at screening).antibody [HCV-Ab] positive at screening and HCV-RNA positive at the same time), or co-infection with hepatitis B and hepatitis C;
Presence of clinically significant acute or chronic pancreatitis; patients at high risk for pancreatitis, e.g., serum amylase and/or lipase concentrations ≥3 times ULN (except when the investigator determines that abnormally elevated amylase and/or lipase are associated with pancreatic cancer);
Patients with any active autoimmune disease or history of autoimmune disease (e.g., the following, but not limited to: autoimmune hepatitis, interstitial pneumonitis, uveitis, enteritis, hepatitis, pituitary gland inflammation, vasculitis, nephritis, and hyperthyroidism; patients with asthma that has completely resolved in childhood and does not require any intervention in adulthood can be included; patients with asthma that requires medical intervention with bronchodilators cannot be Inclusion);
Systemic treatment with corticosteroids (>10 mg/day of prednisone or other equivalent hormone) or other immunosuppressive agents within 2 weeks prior to the first dose; inhaled or topical corticosteroids and adrenal hormone replacement therapy at doses
≤10 mg/day of prednisone efficacy permitted in the absence of active autoimmune disease
Other situations that the researcher felt should not be included.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Baiyong shen, Dr | Contact | 008613901943778 | shenby@shsmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine | Recruiting | Shanghai | China |
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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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| Up to approximately 12 months |
| major pathologic response (MPR, CAP Score 0-1) | Number of Subjects Achieving MPR as a Percentage of Subjects | At the time of surgery |
| Disease-free survival (DFS) | For subjects who achieved R0/R1 resection, the time from the start of surgery to disease recurrence (local or distant) or death from any cause, whichever occurs first | Up to approximately 6 months |
| Event-free survival (EFS) | The time from the first dose of neoadjuvant therapy to the occurrence of any event; events include the occurrence of imaging disease progression (based on the date of the imaging test), the occurrence of disease recurrence (local recurrence or distant recurrence) after surgery, and death from any cause, based on the time of the first occurrence | Up to approximately 6 months |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |