Recruiting PHASE3 Pancreatic Adenocarcinoma

New treatment option for Pancreatic Adenocarcinoma

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

ClinicalTrials.gov ID: NCT06250972

What this study is testing

What is Gemcitabine, Nab-paclitaxel, Irinotecan?

Gemcitabine, Nab-paclitaxel, Irinotecan is an investigational medicine, being studied as a potential treatment for pancreatic adenocarcinoma.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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.
  • Phase 3: a large, late-stage study

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 to 80

You may be able to join 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.

You likely can't join 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.
See the full eligibility criteria
Who can join
  • 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.
What rules you out
  • 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.

The study team makes the final eligibility decision.

Where it's taking place

  • Shanghai, Shanghai Municipality, China

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.