Transcatheter Arterial Infusion to Patients With Advanced Pancreatic Cancer

NCT06196788 | Recruiting Phase 2 DMC

• 1 other identifier: PTCA199-9
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the efficacy of gemcitabine and nab-paclitaxel venous injection plus transcatheter arterial infusion to Patients with Advanced Pancreatic Cancer.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Overall survival，OS

  OS of subjects from recruiting to the time of death from any cause

  At the end of Cycle 1 (each cycle is 28 days)

Secondary Outcomes (3)

• progression-free survival, PFS

  At the end of Cycle 1 (each cycle is 28 days)

• objective response rate (ORR),

  At the end of Cycle 1 (each cycle is 28 days)

• disease control rate (DCR)

  At the end of Cycle 1 (each cycle is 28 days)

Study Arms (1)

gemcitabine and nab-paclitaxel venous injection plus transcatheter arterial infusion

EXPERIMENTAL

nab-paclitaxel (120 mg per square meter of body-surface area) followed by gemcitabine (1000 mg per square meter) on days 1 (venous injection), 8 (venous injection), and 15 (transcatheter arterial infusion) every 4 weeks.

Drug: Gemcitabine; Drug: Nab paclitaxel

Interventions

Gemcitabine DRUG

1000 mg per square meter

gemcitabine and nab-paclitaxel venous injection plus transcatheter arterial infusion

Nab paclitaxel DRUG

120 mg per square meter of body-surface area

gemcitabine and nab-paclitaxel venous injection plus transcatheter arterial infusion

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to understand and the willingness to sign a written informed consent document.
• Age ≥ 18 years and ≤ 80 years.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
• Histologically or cytologically confirmed advanced pancreas adenocarcinoma.
• Primary pancreatic cancer without major anti-cancer treatments.
• Locally advanced, or metastatic pancreatic cancer.
• Presence of at least of one measurable lesion in agreement to RECIST criteria.
• The expected survival ≥ 3 months.
• Adequate organ performance based on laboratory blood tests.
• Patients who are willing or able to comply with study procedures.

You may not qualify if:

• Pregnant or nursing women.
• Patients who have received anti-tumor chemotherapy, radiotherapy, or other treatments.
• The diagnosis was confirmed by pathology as non-adenocarcinoma of pancreas.
• Inflammation of the digestive tract, including pancreatitis, cholecystitis, cholangitis, etc.
• Severe and uncontrollable accompanying diseases that may affect protocol compliance or interfere with the interpretation of results.
• Cardiovascular and cerebrovascular accidents.
• Allergic to study drugs.
• Other serious accompanying illnesses, which, in the researcher's opinion, could seriously adversely affect the safety of the treatment.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Related Publications (4)

• Aigner KR, Gailhofer S, Selak E, Aigner K. Intra-arterial infusion chemotherapy versus isolated upper abdominal perfusion for advanced pancreatic cancer: a retrospective cohort study on 454 patients. J Cancer Res Clin Oncol. 2019 Nov;145(11):2855-2862. doi: 10.1007/s00432-019-03019-6. Epub 2019 Sep 10.

  PMID: 31506738 BACKGROUND

• Liu X, Yang X, Zhou G, Chen Y, Li C, Wang X. Gemcitabine-Based Regional Intra-Arterial Infusion Chemotherapy in Patients With Advanced Pancreatic Adenocarcinoma. Medicine (Baltimore). 2016 Mar;95(11):e3098. doi: 10.1097/MD.0000000000003098.

  PMID: 26986149 BACKGROUND

• Endo S, Kawaguchi S, Terada S, Shirane N. Hepatic Arterial Infusion Chemotherapy for Liver Metastases Following Standard Chemotherapy for Pancreatic Cancer. Intern Med. 2021 Jan 15;60(2):223-229. doi: 10.2169/internalmedicine.5449-20. Epub 2020 Sep 19.

  PMID: 32963157 BACKGROUND

• Qiu B, Zhang X, Tsauo J, Zhao H, Gong T, Li J, Li X. Transcatheter arterial infusion for pancreatic cancer: a 10-year National Cancer Center experience in 115 patients and literature review. Abdom Radiol (NY). 2019 Aug;44(8):2801-2808. doi: 10.1007/s00261-019-02022-2.

  PMID: 31025067 BACKGROUND

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gemcitabine; Taxes

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Economics; Health Care Economics and Organizations

Central Study Contacts

Ying Yang, MD

CONTACT

86 64175590; yangying@fudanpci.org

Guopei Luo, MD

CONTACT

luoguopei@fudanpci.org

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: Professor

Study Record Dates

• First Submitted: December 26, 2023
• First Posted: January 9, 2024
• Study Start: March 1, 2024
• Primary Completion: March 1, 2026
• Study Completion (Estimated): January 1, 2028
• Last Updated: March 21, 2024

Record last verified: 2024-03

Locations

CN (1)