IBI343 Combined With Chemotherapy as Neoadjuvant Therapy in Borderline Resectable Pancreatic Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorZhejiang University
About this trial
This study is a Phase II trial evaluating the safety and efficacy of IBI343 in combination with chemotherapy as neoadjuvant therapy for subjects with borderline resectable pancreatic cancer (BRPC). The study enrolls treatment-naïve subjects with CLDN18.2-positive BRPC, confirmed by imaging and pathological diagnosis. Subjects will receive 4 cycles of neoadjuvant therapy. During or after neoadjuvant therapy, subjects who are unable to undergo radical surgical resection due to disease progression or other reasons will discontinue study treatment. After imaging assessment, subjects deemed eligible for radical resection by a multidisciplinary team (MDT) will undergo radical surgery 14-28 days after the last dose of neoadjuvant therapy . Following surgery, subjects will receive adjuvant therapy with the AG regimen or investigator-selected adjuvant chemotherapy. Adjuvant therapy will begin 21-56 days post-surgery, and the total duration of preoperative neoadjuvant and postoperative adjuvant therapy will be 6 months. Subjects will continue adjuvant therapy until the planned treatment duration is completed, or until disease recurrence, intolerable toxicity, withdrawal of informed consent, loss to follow-up, death, or other treatment discontinuation criteria are met (whichever occurs first). After discontinuation of study treatment, subjects will undergo safety follow-up and survival follow-up.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
(1)Sign a written Informed Consent Form (ICF), willing and able to comply with the visits and related procedures specified in the protocol.
(2)Histopathologically confirmed pancreatic adenocarcinoma.
(3)No evidence of distant metastasis as assessed by imaging (must include chest, abdomen, and pelvis). Bone scan or PET/CT may be performed for confirmation if necessary.
(4)Confirmed borderline resectable pancreatic cancer as assessed by imaging (abdominal contrast-enhanced CT or contrast-enhanced MRI), with resectability determined according to the NCCN 2025.V2 guidelines for pancreatic cancer.
Disqualifiers
(1)Currently participating in another interventional clinical study, excluding observational (non-interventional) clinical studies or being in the survival follow-up phase of an interventional study.
(2)The tumor is a locally recurrent lesion.
(3)Received treatment with a strong cytochrome P450 3A4 (CYP3A4) inhibitor within 2 weeks or 5 half-lives (whichever is longer) before the first dose of the investigational drug.
(4)Underwent biliary stent implantation or PTCD within 7 days before the first dose of the investigational drug.
Trial design
Design model
Single group
Treatments tested in this trial
IBI343
DrugSubjects will receive 4 cycles of neoadjuvant therapy with the following regimen: IBI343 6mg/kg IV D1 Q3W + Gemcitabine 800mg/m² IV D1, D8 Q3W + Nab-paclitaxel 100mg/m² IV D1, D8 Q3W. During or after neoadjuvant therapy, subjects who are unable to undergo radical surgical resection due to disease progression (based on RECIST v1.1) or other reasons will discontinue study treatment. After imaging assessment, subjects deemed eligible for radical resection by a multidisciplinary team (MDT) will undergo radical surgery 14-28 days after the last dose of neoadjuvant therapy (for subjects unable to undergo surgery within this window due to adverse events or other reasons, radical surgery must be performed no later than 42 days after the last dose of neoadjuvant therapy). Following surgery, subjects will receive adjuvant therapy with the AG regimen or investigator-selected adjuvant chemotherapy (gemcitabine monotherapy or gemcitabine combined with capecitabine).
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
Disease Control Rate (DCR)
The proportion of patients who have achieved a best response of either Stable Disease (SD), Partial Response (PR), or Complete Response (CR). It essentially measures the treatment's ability to stop the cancer from growing.
Time frame
Up to 2 yeas3
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
Objective Response Rate (ORR)
The proportion of patients whose tumor shrinks (responds) by a predefined amount from its baseline size for a minimum period of time. It includes two categories of response: Complete Response (CR): The disappearance of all target tumors. Partial Response (PR): A specified minimum decrease (e.g., 30%) in the sum of the diameters of the target tumors.
Time frame
Up to 2 yearsSponsors and contacts
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Source ClinicalTrials.gov
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