HRS-4642 in Combination With Gemcitabine and Albumin-bound Paclitaxel and Adebrelimab for Neoadjuvant and Adjuvant Treatment of Pancreatic Cancer

ConditionPancreatic Cancer

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-80

SponsorRuijin Hospital

About this trial

To evaluate the safety and efficacy of HRS-4642 in Combination With AG and Adebrelimab for Neoadjuvant and Adjuvant Treatment of Pancreatic Cancer

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age: ≥18 and ≤80 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;

Imaging evaluation met the NCCN guidelines definition of resectable pancreatic cancer (including high-risk resectable) and borderline resectable pancreatic cancer.

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

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

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.

Treatment groups

30 Participants

are divided into 1 treatment group

Group A: HRS-4642+AG +AdebrelimabExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Adverse events (AEs)

AEs are assessed by NCI-CTCAE v5.0

Time frame

From the first drug administration to within 30 days for the last dose

Objective Response Rate (ORR)

Evaluated by RECIST v1.1

Time frame

Up to approximately 6 months

Secondary outcomes

pathologic complete response (pCR)

Number of subjects achieving pCR as a percentage of subjects

Time frame

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.

Time frame

Up to approximately 12 months

major pathologic response (MPR, CAP Score 0-1)

Number of Subjects Achieving MPR as a Percentage of Subjects

Time frame

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

Time frame

Up to approximately 6 months