IBI343 Combined With Chemotherapy as Neoadjuvant Therapy in Borderline Resectable Pancreatic Cancer (NCT07415525) | Clinical Trial Compass
Not Yet RecruitingPhase 2
IBI343 Combined With Chemotherapy as Neoadjuvant Therapy in Borderline Resectable Pancreatic Cancer
China40 participantsStarted 2026-02-01
Plain-language summary
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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* (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.
* (5)No prior anti-tumor treatment for the studied disease, including surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.
* (6)Age ≥18 years and ≤75 years, regardless of gender.
* (7)Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1.
* (8)Expected survival ≥12 weeks.
* (9)Adequate bone marrow and organ function.
* (10)Female subjects of childbearing potential or male subjects with female partners of childbearing potential must use effective contraception throughout the treatment period and for 6 months after treatment.
* (11)Confirmed \*CLDN18.2 positivity by pathological tissue testing. \*CLDN18.2 positivity is defined as Claudin18.2 immunohistochemical membrane staining intensity ≥1+ in ≥50% of tumor cells, accepting previous test results, results from the research center, or laboratory test results. Rega…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.