Chemotherapy and Radiotherapy for Advanced Pancreatic Cancer
Radiotherapy to Patients With CA19-9-elevated Advanced Pancreatic Cancer
Recruiting
Phase 3Interventional Study
Pancreatic Adenocarcinoma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 80
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
210 (estimated)
Sponsor
Fudan University · Other
Who this trial is looking for
This trial is looking for adults with advanced pancreatic cancer that have high levels of a specific marker in their blood. Participants will receive a combination of chemotherapy and radiotherapy.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 18 and 80 years old.
I have been diagnosed with advanced pancreatic adenocarcinoma.
I have not become resistant to previous chemotherapy.
I have at least one measurable tumor.
I have high CA19-9 levels over 37 U/mL.
I expect to live at least 3 more months.
My organ function is sufficient based on blood tests.
I agree to use contraception during the study.
You may not be able to join if
I am pregnant or nursing.
I have primary pancreatic cancer.
My CA19-9 level is 37 U/mL or lower.
My cancer is not adenocarcinoma of the pancreas.
I have inflammation of the digestive tract.
I have severe diseases that could affect my safety in the trial.
I have kidney failure or am on dialysis.
I am allergic to oxaliplatin or chemotherapy drugs.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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Status
Eligibility Criteria
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 …
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.
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