Locally Advanced or Metastatic Pancreatic Cancer With
Conditions
Brief summary
This study is a randomized, open-label, multicenter Phase II clinical trial designed to evaluate the Safety, Tolerability and Preliminary Efficacy of HRS-4642 Combination with Other Antitumor Therapies in Patients with Solid Tumors
Interventions
DRUGHRS-4642;Adebrelimab Injection; nab-paclitaxel; gemcitabine
HRS-4642 combination with Adebrelimab Injection, nab-paclitaxel in combination with gemcitabine
DRUGHRS-4642;nab-paclitaxel; gemcitabine
nab-paclitaxel in combination with gemcitabine
Sponsors
Shanghai Hengrui Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age range of 18-75 years old (inclusive of both ends), gender not limited when signing the informed consent form 2. ECOG performance status 0 or 1 3. Life expectancy of greater than or equal to 12 weeks. 4. Subjects with unresectable local advanced or metastatic pancreatic cancer, and pancreatic duct adenocarcinoma confirmed by histopathology 5. Provide tumor tissue blocks fixed in formalin, embedded in paraffin, or unstained tumor specimen sections, which can be archived or freshly obtained within 3 years prior to the first study treatment (fresh acquisition is preferred). 6. At least one measurable lesion is present according to the efficacy evaluation criteria for pancreatic cancer (RECIST 1.1)
Exclusion criteria
1. Accompanied by untreated or active central nervous system (CNS) tumor metastasis 2. Failure to recover toxicity and/or complications from previous interventions to NCI-CTCAE ≤ Level 1 or the levels specified by inclusion and
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival (PFS) | From the date of first dose of study drug until progressive disease (PD), death, whichever occurs first, assessed up to 16 months | PFS is defined as the time from the date of first dose of study drug to the date of the first documentation of disease progression or date of death, whichever occurs first. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) | up to 10 months following the date the last patient was randomized | Objective response is defined as a best confirmed response of CR or PR by RECIST v1.1 as assessed by the investigator. |
| disease control rate (DCR) | up to 10 months following the date the last patient was randomized | Disease Control Rate (DCR) is defined as the frequency and percentage of participants with stable disease (SD) or CR or PR. |
| Duration of response (DoR) | up to 10 months following the date the last patient was randomized | Duration of Response (DOR) was defined as the duration between the date of first documented Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) and the date of first documented radiographic progression or death due to any cause as assessed by investigator according to RECIST v1.1. |
| Overall survival (OS) | From study start until target OS events have occurred (approximately 20 months after last patient enrollment) | Overall Survival (OS) is defined as the time from the date of first dose to the date of death due to any cause. |
Countries
China
Contacts
Primary ContactZengquan Gu
Outcome results
None listed