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New treatment option for Pancreatic Cancer
Official title Radiotherapy With GX Regimen as Adjuvant Therapy for High-risk Patients Following Pancreatic Cancer Surgery
ClinicalTrials.gov ID: NCT07632118
What this study is testing
What is GX group?
GX group is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for pancreatic cancer.
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
- Pancreatic cancer is a highly fatal malignant tumor. Simple surgical operations can no longer meet the treatment needs of pancreatic cancer patients.
- 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 75
You may be able to join if
- Understand and voluntarily participate in this study and sign the informed consent form
- Age ≥18 years old and ≤75 years old, male and female.
- Confirmed as pancreatic ductal adenocarcinoma by histopathology or cytology, with no evidence of distant metastasis confirmed by imaging.
- The preoperative neoadjuvant chemotherapy regimen is not limited and should not exceed 4 cycles. After the operation was completed, at least one...
- No disease progression was evaluated by CT or MRI after the operation.
You likely can't join if
- Had received radiotherapy, palliative chemotherapy or other targeted or immunotherapy for anti-tumor treatment before pancreatic tumor resection;
- Suffering from severe underlying diseases, including but not limited to: active infections that require systemic medication treatment; Uncontrolled...
- There is a history of other malignant tumors (cured basal cell carcinoma of the skin and cervical carcinoma in situ)
- There is bleeding or coagulation disorder;
- Postoperative complications such as bleeding, pancreatic fistula, gastric emptying disorder, abdominal infection, and biliary fistula occur, which...
- Those who are allergic to the drugs or their components used in this plan;
See the full eligibility criteria
- Understand and voluntarily participate in this study and sign the informed consent form
- Age ≥18 years old and ≤75 years old, male and female.
- Confirmed as pancreatic ductal adenocarcinoma by histopathology or cytology, with no evidence of distant metastasis confirmed by imaging.
- The preoperative neoadjuvant chemotherapy regimen is not limited and should not exceed 4 cycles. After the operation was completed, at least one postoperative high-risk factor was present :R1/R2 resection. Regional LN...
- No disease progression was evaluated by CT or MRI after the operation.
- The people have sufficient organ and bone marrow functions: absolute neutrophil count ≥1.5×109, platelet count ≥80×109, hemoglobin ≥90g/L; Total bilirubin levels ≤1.5 times the upper limit of normal (ULN), aspartate...
- ECOG PS score 0-1;
- The expected postoperative survival period is ≥3 months;
- Women of childbearing age who are not pregnant and have no pregnancy plans. Patients of childbearing age and their spouses are willing to take contraceptive measures that have been medically approved.
- Had received radiotherapy, palliative chemotherapy or other targeted or immunotherapy for anti-tumor treatment before pancreatic tumor resection;
- Suffering from severe underlying diseases, including but not limited to: active infections that require systemic medication treatment; Uncontrolled diabetes and hypertension; Negligent compensatory heart failure (NYHA...
- There is a history of other malignant tumors (cured basal cell carcinoma of the skin and cervical carcinoma in situ)
- There is bleeding or coagulation disorder;
- Postoperative complications such as bleeding, pancreatic fistula, gastric emptying disorder, abdominal infection, and biliary fistula occur, which prevent the patient from receiving adjuvant treatment within 12 weeks...
- Those who are allergic to the drugs or their components used in this plan;
- Known to be infected with HIV or syphilis, or currently in the active stage of hepatitis (hepatitis B, hepatitis C);
- Female people who are pregnant or breastfeeding, or plan to become pregnant during the study period, or female spouses of male people;
- The people had poor compliance and were unable to follow the various procedures, restrictions or requirements of the study, etc.
- There are other reasons that the researcher deems unsuitable for participation in this study.
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, Tianjin 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 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, Tianjin 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.