NCT07415525

IBI343 Combined With Chemotherapy as Neoadjuvant Therapy in Borderline Resectable Pancreatic Cancer

A Phase II Clinical Study Evaluating the Safety and Efficacy of IBI343 Combined With Chemotherapy as Neoadjuvant Therapy in Subjects With Borderline Resectable Pancreatic Cancer

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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 (contrast-enhanced CT or MRI) and pathological diagnosis. Subjects 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). 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.

Conditions

• Pancreatic Cancer
• Borderline Resectable Pancreatic Adenocarcinoma

Interventions

Type	Name	Description
DRUG	IBI343	Subjects 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).

Timeline

• Start date: 2026-02-01
• Primary completion: 2028-12-31
• Completion: 2030-12-31
• First posted: 2026-02-17
• Last updated: 2026-02-17

Locations

1 site across 1 country: China