An Exploratory Clinical Study of HRS-4642 in Combination With Immunotherapy and Chemotherapy for Pancreatic Cancer

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Zhongshan Hospital

About this trial

To evaluate the safety and efficacy of HRS-4642 in combination with immunotherapy and chemotherapy in borderline resectable, locally advanced/metastatic pancreatic cancer

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age: ≥18 years old, male or female;

Pathologically or cytologically confirmed ductal adenocarcinoma of the pancreas; and subjects must have at least one measurable lesion as defined by RECIST v1.1;

Arm 1 included patients with locally advanced or metastatic pancreatic cancer whose imaging assessment met the guideline definition, and Arm 2 included patients with borderline resectable pancreatic cancer whose imaging assessment met the guideline definition;

Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;

Disqualifiers

Previously received any systemic therapy, including systemic chemotherapy, immunotherapy, targeted therapy, and anti-tumor Chinese medicine;

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • HRS-4642

    Drug

    HRS-4642 in Combination with Immunotherapy and Chemotherapy

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Arm1:locally advanced/metastatic pancreatic cancerExperimental treatment 1 intervention
Group B: Arm 2: borderline resectable pancreatic cancerExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Adverse events (AEs)

Time frame
From the first drug administration to within 90 days for the last dose
2

Arm 1:Objective Response Rate (ORR)

Time frame
Up to approximately 12 months
3

Arm 2:18m-OS rate

Overall survival (OS):The OS is defined as 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.

Time frame
Up to approximately 18 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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