Radiotherapy to Patients With CA19-9-elevated Advanced Pancreatic Cancer

NCT06250972 | Recruiting Phase 3 DMC

• 1 other identifier: PTCA199-11
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the efficacy of chemotherapy plus radiotherapy to patients with CA19-9-elevated Advanced Pancreatic Cancer who are not refractory to chemotherapy.

Conditions

Pancreatic Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• progression-free survival, PFS

  PFS of subjects from recruiting to the time of disease progression

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

Secondary Outcomes (3)

• Overall survival，OS

  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 (2)

chemotherapy

ACTIVE COMPARATOR

Continuing chemotherapy using the previous regimen

Drug: Gemcitabine, Nab-paclitaxel, Irinotecan; Radiation: Intensity-Modulated Radiation Therapy (IMRT)

Radiotherapy

EXPERIMENTAL

Patients will be recommended to receive Intensity-Modulated Radiation Therapy (IMRT) after about 2\~6 cycles of chemotherapy. Other radiation therapies include stereotactic body radiotherapy (SBRT) and proton could be administered.

Radiation: Intensity-Modulated Radiation Therapy (IMRT)

Interventions

Gemcitabine, Nab-paclitaxel, Irinotecan DRUG

continuing chemotherapy using the previous regimen until disease progression

chemotherapy

Intensity-Modulated Radiation Therapy (IMRT) RADIATION

Receive Intensity-Modulated Radiation Therapy (IMRT) after about 2\~6 cycles of chemotherapy.

Radiotherapy; chemotherapy

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.
• Patients who are not refractory to previous chemotherapy and who have not received radiotherapy.
• Locally advanced pancreatic cancer.
• Baseline serum CA19-9 \> 37 U/mL, and CA19-9 level within normal range (≤37 U/mL) after chemotherapy .
• 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.
• Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation.

You may not qualify if:

• Pregnant or nursing women.
• Primary pancreatic cancer.
• Baseline serum CA19-9 ≤ 37 U/mL.
• 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.
• Renal insufficiency or dialysis
• Other serious accompanying illnesses, which, in the researcher's opinion, could seriously adversely affect the safety of the treatment.
• Patients who are allergic to oxaplatin or other chemotherapy drugs.
• Patients who are unwilling or unable to comply with study procedures.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Related Publications (3)

• Zhu X, Xiao Z, Liu H, Zhang P, Deng S, Ding L, Feng J, Luo J, Ni Q, Luo G, Yu X. Pancreatic Cancer: An Exocrine Tumor With Endocrine Characteristics. Ann Surg. 2024 Dec 1;280(6):e17-e25. doi: 10.1097/SLA.0000000000006168. Epub 2023 Dec 5.

  PMID: 38050737 BACKGROUND

• Luo G, Jin K, Deng S, Cheng H, Fan Z, Gong Y, Qian Y, Huang Q, Ni Q, Liu C, Yu X. Roles of CA19-9 in pancreatic cancer: Biomarker, predictor and promoter. Biochim Biophys Acta Rev Cancer. 2021 Apr;1875(2):188409. doi: 10.1016/j.bbcan.2020.188409. Epub 2020 Aug 19.

  PMID: 32827580 BACKGROUND

• Luo G, Liu C, Guo M, Long J, Liu Z, Xiao Z, Jin K, Cheng H, Lu Y, Ni Q, Yu X. CA19-9-Low&Lewis (+) pancreatic cancer: A unique subtype. Cancer Lett. 2017 Jan 28;385:46-50. doi: 10.1016/j.canlet.2016.10.046. Epub 2016 Nov 10.

  PMID: 27840089 BACKGROUND

MeSH Terms

Interventions

Gemcitabine; 130-nm albumin-bound paclitaxel; Irinotecan; Radiotherapy, Intensity-Modulated

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Camptothecin; Alkaloids; Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Officials

• Guopei Luo, MD

  Fudan University

  PRINCIPAL INVESTIGATOR

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 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 31, 2024
• First Posted: February 9, 2024
• Study Start: May 15, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: August 7, 2025

Record last verified: 2025-02

Locations

CN (1)