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

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.

Study Overview

• Status: Recruiting
• Conditions: Pancreatic Adenocarcinoma Locally Advanced
• Intervention / Treatment: Radiation: Cryoablation; Drug: Dual-Function Antibody PD-1/CTLA-4

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Zhongmin Wang, Doctor; Phone Number: 0086-13901848333; Email: wzm11896@rjh.com.cn
• Study Contact Backup: Name: Jingfeng Li, Doctor; Phone Number: 0086-13918536451; Email: 13918536451@163.com

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 2000010
      • Recruiting
      • Department of Radiology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
      • Contact: Zhongmin Wang; Phone Number: 0086-13901848333; Email: wzm11896@rjh.com.cn
      • Contact: Jingfeng Li; Phone Number: 0086-13918536451; Email: 13918536451@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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:
  1. Total bilirubin ≤ 2× upper limit of normal (ULN) (for subjects with biliary obstruction, after biliary drainage ≤ 2.5 × ULN);
  2. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) in metastatic subjects ≤ 5 × ULN;
  3. Albumin level ≥ 28 g/L;
  4. Creatinine clearance rate ≥ 60 ml/min; c. Cardiac function tests:
  1. Normal electrocardiogram (ECG) or ECG abnormalities deemed clinically insignificant by the investigator;
  2. Left ventricular ejection fraction (LVEF) ≥ lower limit of normal;
• At least 3 weeks post-surgery, radiotherapy, chemotherapy, or other anti-tumor treatments, with general physical condition or related adverse reactions having recovered (toxicity ≤ grade 1) or stabilized;
• Willing to participate and sign the informed consent form;
• Good compliance and agreement to cooperate with survival follow-up.

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;
• Women of childbearing potential with a positive blood (urine) pregnancy test during the screening period (both male and female subjects should use reliable contraception during the trial and for 3 months after the last dose to prevent pregnancy);
• Subjects with other medical or social issues that, in the investigator's judgment, might affect their ability to sign informed consent, participation in the trial, or interpretation of the trial results;
• Patients with an estimated survival time of ≤ 3 months are not included in this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cryoablation Combined with the Dual-Function Antibody PD-1/CTLA-4	Radiation: Cryoablation; Cryoablation for pancreatic tumor; Drug: Dual-Function Antibody PD-1/CTLA-4; Dual-Function Antibody PD-1/CTLA-4 iv. injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall Survival	From enrollment to the death from any cause, assessed up to 18 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Progression Free Survival	From enrollment to tumor progression or date of death from any cause, whichever came first, assessed up to 18 months

Collaborators and Investigators

• Sponsor: Ruijin Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): December 15, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: December 14, 2025
• First Submitted That Met QC Criteria: December 14, 2025
• First Posted (Actual): December 29, 2025

Study Record Updates

• Last Update Posted (Actual): December 29, 2025
• Last Update Submitted That Met QC Criteria: December 14, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Surgical Procedures, Operative; Ablation Techniques; Cryosurgery
• Other Study ID Numbers: 2025-609

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No