Cadonilimab Plus mFOLFIRINOX as Conversion Therapy in LAPC

NCT06153368 | Unknown Phase 2

• 1 other identifier: 2023-SR-566
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, single arm, single center, phase II study of cadonilimab plus mFOLFIRINOX as conversion therapy in patients with locally advanced pancreatic cancer.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  ORR is defined as the percentage of participants who have a confirmed complete response or partial response according to RECIST 1.1.

  Up to 1 year

Secondary Outcomes (3)

• Progression free survival (PFS)

  Up to two years

• Overall survival (OS)

  Up to two years

• Adverse events (safety)

  Up to two years

Study Arms (1)

Cadonilimab

EXPERIMENTAL

Drug：Cadonilimab 6 mg/kg，IVD，D1，Q2W Drug：mFOLFIRINOX mFOLFIRINOX（Oxaliplatin 85 mg/m2 IV over 4 hours ; Irinotecan 150 mg/m2 IV over 90 minutes ; Leucovorin(l-LV) 400 mg/m2 IV over 2 hours 5-fluorouracil 2.4 g/m2 for 46 hours continuous infusion.） on days 2 of a 14-day cycle.

Drug: Cadonilimab+mFOLFIRINOX

Interventions

Cadonilimab+mFOLFIRINOX DRUG

Cadonilimab 6 mg/kg，IVD，D1，Q2W +mFOLFIRINOX（Oxaliplatin 85 mg/m2 IV over 4 hours ; Irinotecan 150 mg/m2 IV over 90 minutes ; Leucovorin(l-LV) 400 mg/m2 IV over 2 hours 5-fluorouracil 2.4 g/m2 for 46 hours continuous infusion.） on days 2 of a 14-day cycle.

Also known as: Cadonilimab+Oxaliplatin+ Irinotecan+ Leucovorin+ 5-fluorouracil

Cadonilimab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have histologically or cytologically confirmed adenocarcinoma of the exocrine pancreas.
• Patients must have locally advanced pancreatic cancer (LAPC).
• Patients must have LAPC evaluated by radiologist and/or surgeon according to either abdominal CT or MRI, or intra-operative findings.
• Locally advanced unresectable disease was defined by CT or MRI images as low-density tumor (primary and/or lymphadenopathy) with
• extension to the celiac axis or superior mesenteric artery,
• occlusion of the superior mesenteric-portal venous confluence
• aortic, inferior vena cava (IVC) invasion or encasement
• invasion of superior mesenteric vein below transverse mesocolon or unresectable after surgical exploration.
• Those who had superior mesenteric vein impingement, superior mesenteric artery abutment were defined as borderline resectable.
• Those who had superior mesenteric vein occlusion, superior mesenteric artery encasement were defined as unresectable.
• Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>20 mm with conventional techniques or as \>10 mm with spiral CT scan. See section 8.2 for the evaluation of measurable disease.
• Age ≥18years and ≤75 years.
• Eastern Cooperative Oncology Group performance score of 0 or 1; see Appendix A.
• Patients must have normal organ and marrow function
• Patients who present with jaundice will be allowed to enroll after control with temporary or permanent internal/external drainage.

You may not qualify if:

• Patients with distant metastases are not eligible.
• Patients with endocrine or acinar pancreatic carcinoma.
• Patients may be receiving any steroid, immunologic or other investigational agents within 4 weeks prior to enrollment.
• Patients who have had prior chemotherapy or radiotherapy are not eligible.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agents used in the study.
• Patients who have above grade II peripheral neuropathy.
• Patients who had non-curable second primary malignancy within five years, except for non-melanoma skin cancer.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Pregnant women are excluded from this study because the study agents has the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with study agents, breastfeeding should be discontinued if the mother is treated with the study agents.
• Those who are immuno-compromised or receiving immuno-suppressive therapy are excluded from the study because of increased risk of lethal infections and possible pharmacokinetic interactions with study agent administered during the study.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, 210029, China

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Rong K Jiang, MD

  The First Affiliated Hospital with Nanjing Medical University

  STUDY CHAIR

Central Study Contacts

Rong K Jiang, MD

CONTACT

+8615312995688; jiangkuirong@njmu.edu.cn

Min Tu, MD

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: November 23, 2023
• First Posted: December 1, 2023
• Study Start: December 19, 2023
• Primary Completion: November 27, 2024
• Study Completion: November 27, 2025
• Last Updated: December 7, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)