HRS-4642 in Combination With AG 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 for Neoadjuvant and Adjuvant Treatment of Pancreatic Cancer
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
DrugHRS-4642 in Combination With Gemcitabine and Albumin-bound Paclitaxel will be administrated per dose level in which the patients are assigned.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: HRS-4642, Gemcitabine and Albumin-bound PaclitaxelExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 dose2
Objective Response Rate (ORR)
Evaluated by RECIST v1.1
Time frame
Up to approximately 6 monthsSecondary outcomes
1
Total resection rate
Percentage of subjects who received surgical treatment as a proportion of all subjects
Time frame
At the time of surgery2
pathologic complete response (pCR)
Number of subjects achieving pCR as a percentage of subjects
Time frame
At the time of surgery3
R0 resection rate
Number of Subjects Achieving R0 Removal as a Percentage of Subjects
Time frame
At the time of surgery4
major pathologic response (MPR, CAP Score 0-1)
Number of Subjects Achieving MPR as a Percentage of Subjects
Time frame
At the time of surgeryOther outcomes
1
CA19-9 response rate
Time frame
Up to approximately 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Ruijin Hospital
Lead sponsor
Jiangsu HengRui Medicine Co., Ltd.
Collaborator
Source ClinicalTrials.gov