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Cryoablation Combined With the Dual-Function Antibody PD-1/CTLA-4 for the Treatment of LAPC Following Failure of First-Line AG Therapy | Clinical Trials | Clareo Health

RECRUITINGPHASE2

Cryoablation Combined With the Dual-Function Antibody PD-1/CTLA-4 for the Treatment of LAPC Following Failure of First-Line AG Therapy

A Single-Arm, Open-Label Clinical Study of Cryoablation Combined With the Dual-Function Antibody PD-1/CTLA-4 (Apalulizumab) for the Treatment of Locally Advanced Pancreatic Cancer Following Failure of First-Line AG Therapy

NCT07306286•Ruijin Hospital

View on ClinicalTrials.gov

Summary

The study explores the efficacy and safety of cryoablation combined with the dual-function antibody PD-1/CTLA-4 (Apalulizumab) for the treatment of locally advanced pancreatic cancer following failure of first-line AG therapy. This research aims to accumulate more clinical evidence and treatment options for second-line therapy in locally advanced pancreatic cancer following failure of first-line regimen.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Aged 18 years and above, with no gender restrictions;
•Pathologically confirmed pancreatic cancer (originating from the pancreatic ductal epithelium), with clinical records indicating locally advanced pancreatic cancer;
•Clinical records indicating previous failure of standard AG treatment (having received at least one cycle of standardized chemotherapy, with disease progression or intolerance during treatment, or disease progression after the end of treatment);
•Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2;
•Adequate organ function, meeting the following criteria:
•a. Hematological tests:
•1. Neutrophils ≥ 1.5 × 10⁹ /L;
•2. White blood cells ≥ 3.0 × 10⁹ /L;
•3. Platelets ≥ 85 × 10⁹ /L;
•4. Hemoglobin ≥ 70 g/L; b. Biochemical tests:
+11 more criteria

Exclusion Criteria

•Metastatic pancreatic cancer or has previously undergone interventional treatment for pancreatic cancer;
•Subjects with ascites requiring clinical intervention (including moderate to large amounts of ascites; subjects with ascites need to be stable for more than 4 weeks after drainage);
•Clinically severe gastrointestinal diseases (including bleeding, infectious inflammation, perforation, obstruction, or diarrhea greater than grade 1);
•NRS pain score ≥ 4 after standardized treatment with analgesics;
•Second primary malignancy within 5 years (except cured carcinoma in situ, basal cell, or squamous cell skin cancer; subjects with other previous tumors can be enrolled if there has been no recurrence within 5 years);
•Uncontrolled cardiovascular or cerebrovascular diseases with clinical symptoms, including but not limited to: ① NYHA class III or higher heart failure; ② unstable angina; ③ myocardial infarction or stroke within 6 months; ④ supraventricular or ventricular arrhythmias requiring treatment or intervention; ⑤ uncontrolled hypertension (systolic blood pressure \> 150 mmHg and/or diastolic blood pressure \> 90 mmHg despite optimal treatment);
•Known active hepatitis B subjects (HBsAg positive and HBV DNA ≥ 10³ copies or ≥ 1000 U/ml);
•Active infection or unexplained fever \> 38.5°C during the screening period or on the day of administration (subjects with fever caused by tumors can be enrolled as judged by the investigator), which, in the investigator\'s judgment, would affect the subject\'s participation in this trial or interfere with the evaluation of efficacy;
•Known allergy to any components of irinotecan hydrochloride liposome, other liposomes, oxaliplatin, 5-FU, LV, or S-1;
•Pregnant or breastfeeding women;
+3 more criteria

Locations (1)

Department of Radiology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

December 15, 2025

Primary Completion Date

August 1, 2027

Completion Date

August 1, 2027

Last Updated

December 29, 2025

Enrollment

ESTIMATED participants

Conditions

Pancreatic Adenocarcinoma Locally Advanced

Interventions

Cryoablation

RADIATION

Dual-Function Antibody PD-1/CTLA-4

DRUG

Contacts

Zhongmin Wang, Doctor

CONTACT

0086-13901848333 wzm11896@rjh.com.cn

Jingfeng Li, Doctor

CONTACT

0086-13918536451 13918536451@163.com

Effect on Tumor Perfusion of a Chemotherapy Combining Gemcitabine and Nab-paclitaxel (Abraxane) in Pancreatic Cancer

NCT01715142

Pancreatic Adenocarcinoma ResectablePancreatic Adenocarcinoma Locally Advanced+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 29, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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