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

Pancreatic Adenocarcinoma Clinical Trial

— PTCA199-11  

Official title:

Radiotherapy Plus Chemotherapy to Patients With CA19-9-elevated Advanced Pancreatic Cancer Who Are Not Refractory to Chemotherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06250972
• Other study ID #: PTCA199-11
• Status: Recruiting
• Phase: Phase 3
• Start date: May 15, 2024
• Est. completion date: May 1, 2028

Study information

• Verified date: February 2024
• Source: Fudan University
• Contact: Ying Yang, MD
• Phone: 86 64175590
• Email: yangying[@]fudanpci.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Pancreatic adenocarcinoma (PDAC) is a highly lethal malignancy with a 5-year survival less than 10%. Approximately 80% of patients with pancreatic cancer are diagnosed at an advanced stage. Chemotherapy is one of the major treatments for advanced pancreatic cancer. In 2011, the PRODIGE trial has shown that oxaliplatin, irinotecan, fluorouracil, and leucovorin (FOLFIRINOX) was associated with a survival advantage but had increased toxicity.

Carbohydrate antigen 19-9 (CA19-9) is the most widely used biomarker in pancreatic cancer. Circulating CA19-9 levels are positively correlated with tumor burden and stage in pancreatic cancer with a diagnostic sensitivity of approximately 80%, suggesting that approximately 20% of patients have normal CA19-9 levels. It is well recognized that Lewis (-) individuals, constituting approximately 10% of the population, have low or no secretion of CA19-9 due to the lack of critical enzyme involved in CA19-9 biosynthesis. Thus, approximately 10% of patients with pancreatic cancer have normal CA19-9 levels regardless of tumor stage. Our previously retrospective study has shown that CA19-9-normal advanced pancreatic cancer may be more sensitive to chemotherapy combined with radiotherapy.

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. Progression-free survival (PFS), objective response rate (ORR), overall survival (OS) and disease control rate (DCR) are measured every four weeks.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: May 1, 2028
• Est. primary completion date: May 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Pancreatic Adenocarcinoma

Intervention

Drug:
• Gemcitabine, Nab-paclitaxel, Irinotecan
continuing chemotherapy using the previous regimen until disease progression

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

Locations

Country	Name	City	State
China	Shanghai Cancer Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

References & Publications (3)

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 202 — View Citation

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. — View Citation

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. 2023 Dec 5. doi: 10.1097/SLA.0000000000006168. Online ahead of print. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	objective response rate (ORR)	CR + PR	At the end of Cycle 1 (each cycle is 28 days)
Secondary	disease control rate (DCR)	CR + PR + SD	At the end of Cycle 1 (each cycle is 28 days)