HRS-4642 in Combination With Nimotuzumab and Chemotherapy for BRPC With KRAS G12D Mutation
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorZhejiang University
About this trial
This study is a Phase II clinical trial that plans to enroll 40 patients with borderline resectable pancreatic cancer harboring a KRAS G12D mutation, aiming to evaluate the efficacy of HRS-4642 in combination with Nimotuzumab and AG in borderline resectable pancreatic cancer. The study process includes a screening period (from the signing of the informed consent form until the first dose), a treatment period (from the first dose to the discontinuation of study treatment), and a follow-up period (safety follow-up and survival follow-up after the discontinuation of study treatment).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged between 18 and 75 years (inclusive).
Histopathologically confirmed pancreatic cancer (originating from the pancreatic ductal epithelium).
Radiologically confirmed borderline resectable pancreatic cancer (according to the latest NCCN guidelines definition), with no distant metastases.
Tumor tissue testing confirms KRAS G12D mutation.
Disqualifiers
Major surgical procedure or significant traumatic injury within 4 weeks prior to enrollment, or palliative local therapy (including but not limited to palliative radiotherapy, interventional therapy) within 2 weeks prior to enrollment.
Treatment with any investigational drug from another clinical study within 4 weeks prior to enrollment, except for participation in an observational (non-interventional) clinical study or the follow-up phase of an interventional study.
Use of strong inhibitors or inducers of hepatic drug-metabolizing enzymes CYP3A4 or CYP2C8 within 14 days prior to enrollment.
2. Acute or chronic pancreatitis requiring clinical intervention.
Trial design
Design model
Single group
Treatments tested in this trial
HRS-4642+AG+Nimotuzumab
DrugHRS-4642 Injection: 500 mg intravenous infusion on Day 1, and 1200 mg intravenous infusion on Day 8, every 3 weeks per cycle. A total of 4 cycles are planned in the neoadjuvant therapy phase, and up to a maximum of 4 cycles in the adjuvant therapy phase. Nimotuzumab: 400 mg on Days 1 and 8, every 3 weeks per cycle. A total of 4 cycles are planned in the neoadjuvant therapy phase, and up to a maximum of 4 cycles in the adjuvant therapy phase. Paclitaxel for Injection (Albumin-bound): 125 mg/m² on Days 1 and 8, every 3 weeks per cycle. A total of 4 cycles are planned in the neoadjuvant therapy phase, and up to a maximum of 4 cycles in the adjuvant therapy phase. Gemcitabine: 1000 mg/m² on Days 1 and 8, every 3 weeks per cycle. A total of 4 cycles are planned in the neoadjuvant therapy phase, and up to a maximum of 4 cycles in the adjuvant therapy phase. The recommended adjuvant treatment regimen is to continue HRS-4642 + Nimotuzumab + AG for 4 cycles.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Treatment groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
12-month Event-Free Survival (EFS) rate
The proportion of patients who had tumor progression, tumor recurrence (local, regional or distant) or death within 1 year after surgery, whichever occurred first
Time frame
Up to one yearSecondary outcomes
1
Event Free Survival, EFS
From treatment to the date of the first documented tumor progression, tumor into recurrence or death from any cause, whichever occurred first
Time frame
Up to 2 years2
Surgical resection rate
The proportion of patients who receive the radical resection
Time frame
Up to 1 year3
R0 resection rate
R0 resection rate is the percentage of patients who undergo a surgical procedure where the surgeon successfully removes the entire visible tumor and a microscopic examination confirms that no cancer cells are left at the edges (margins) of the removed tissue.
Time frame
Up to 1 year4
Pathological Complete Response (pCR) Rate
The percentage of patients who, after pre-surgical (neoadjuvant) therapy, have no viable cancer cells detected in the tumor tissue and lymph nodes that are removed during subsequent surgery when examined under a microscope by a pathologist.
Time frame
Up to 1 yearSponsors and contacts
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Source ClinicalTrials.gov