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Neoadjuvant HRS-4642 Plus Chemotherapy With or Without Immunotherapy for Pancreatic Cancer

ConditionPancreatic Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorChanghai Hospital

About this trial

To evaluate the safety and efficacy of neoadjuvant HRS-4642 plus chemotherapy with or without adebrelimab in patients with pancreatic ductal adenocarcinoma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male and female participants aged 18-70 (including those who are 18 and 70 years old)；

Pathologically or cytologically confirmed ductal adenocarcinoma of the pancreas; and subjects must have at least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1);

Life expectancy ≥ 12 weeks;

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

Disqualifiers

Prior receipt of any anti-tumor therapy, including but not limited to systemic chemotherapy, radiotherapy, interventional therapy, immunotherapy, targeted therapy, and anti-tumor traditional Chinese medicine therapy;

Presence of distant metastatic lesions confirmed by imaging;

Known hypersensitivity to the investigational drug or any of its excipients;

Presence of any serious or uncontrolled systemic disease;

Trial design

Design model

Parallel

Treatments tested in this trial

  • HRS-4642+NALIRIFOX

    Drug

    HRS-4642+NALIRIFOX

  • HRS-4642+NALIRIFOX+Adebrelimab

    Drug

    HRS-4642+NALIRIFOX+Adebrelimab

  • HRS-4642+NALIRIFOX+Adebrelimab

    Drug

    HRS-4642+NALIRIFOX+Adebrelimab

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: Arm 1：HRS-4642+NALIRIFOXExperimental treatment 1 intervention
Group B: Arm 2：HRS-4642+NALIRIFOX+Adebrelimab（4 cycles of neoadjuvant therapy）Experimental treatment 1 intervention
Group C: Arm 3：HRS-4642+NALIRIFOX+Adebrelimab（6 cycles of neoadjuvant therapy）Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Adverse events (AEs)

Time frame
From the first drug administration to within 30 days or within 60 days after the last dose of adebrelimab for the last dose
2

Objective Response Rate (ORR) based on Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1)

Time frame
Once every 2 cycles from enrollment through the neoadjuvant and adjuvant therapy periods or until disease progression; the evaluation period is up to 6 months

Secondary outcomes

1

Pathologic Complete Response Rate (pCR)

Time frame
At the time of surgery
2

R0 (microscopically margin-negative) resection rate

Time frame
At the time of surgery
3

Major Pathologic Response Rate (MPR)

Time frame
At the time of surgery

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Changhai Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: