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- Klinische proef NCT07632118
Radiotherapy With GX Regimen as Adjuvant Therapy for High-risk Patients Following Pancreatic Cancer Surgery
4 juni 2026 bijgewerkt door: Tianjin Medical University Cancer Institute and Hospital
A Prospective, Multicenter, Randomized Controlled Phase III Study on Radiotherapy Combined With GX Regimen as Adjuvant Therapy for High-risk Patients Following Pancreatic Cancer Surgery
Pancreatic cancer is a highly fatal malignant tumor.
Simple surgical operations can no longer meet the treatment needs of pancreatic cancer patients.
Postoperative adjuvant chemotherapy has a significant effect, which can effectively prevent or delay tumor recurrence and prolong the overall survival period of pancreatic cancer patients.
Based on this, many guidelines both at home and abroad actively recommend that pancreatic cancer patients receive adjuvant chemotherapy after surgery (if there are no contraindications).
Radiotherapy is one of the most commonly used local treatment methods.
It can be used as a neoadjuvant or adjuvant therapy to increase the tumor resection rate or reduce the recurrence rate, or as a treatment approach for locally unresectable pancreatic cancer to improve local control.
After complete gross resection of pancreatic cancer, the role of radioadjuvant therapy has always been controversial, and its indications for use remain unclear.
However, recent clinical studies using modern radiotherapy equipment and techniques have shown that an increasing amount of data indicates that radiotherapy can benefit in the treatment of neoadjuvant, adjuvant and locally advanced pancreatic cancer.
Evidence supporting adjuvant radiotherapy after pancreatectomy remains scarce.
Therefore, whether screening high-risk factor populations for adjuvant radiotherapy may improve the prognosis of pancreatic cancer is an important research.
Studie Overzicht
Toestand
Werving
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Geschat)
288
Fase
- Fase 3
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Maobin Meng
- Telefoonnummer: 022-23340123-1111
- E-mail: mmeng@tmu.edu.cn
Studie Locaties
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Tianjin Municipality
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Tianjin, Tianjin Municipality, China, 300060
- Werving
- Tianjin medical university hospital and institute
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Hoofdonderzoeker:
- Jihui Hao
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Contact:
- Maobin Meng
- Telefoonnummer: (022)23340123-6417
- E-mail: mmeng@tmu.edu.cn
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Onderonderzoeker:
- Maobin Meng
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
Inclusion 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 transfer Neurovascular invasion The pathology is poorly differentiated. Tumor height >4cm;
- No disease progression was evaluated by CT or MRI after the operation.
- The subjects 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 aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤2.5 times ULN. Serum creatinine ≤1.5 times ULN or creatinine clearance ≥60 ml/min(Cockcroft-Gault formula);
- 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.
Exclusion Criteria:
- 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 grades III and IV), unstable angina, and acute myocardial infarction occurred within 3 months before enrollment. Malignant peritoneal effusion or pleural effusion; Severe portal hypertension or imaging manifestations of cavernous changes in the portal vein; Gastric outlet obstruction, respiratory insufficiency (requiring oxygen inhalation) and severe lung diseases; Central nervous system diseases, mental disorders;
- 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 after the operation.
- 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 subjects who are pregnant or breastfeeding, or plan to become pregnant during the study period, or female spouses of male subjects;
- The subjects 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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Radiotherapy plus GX group
After 3 cycles of GX chemotherapy, capecitabine is taken orally simultaneously with radiotherapy.
After concurrent chemoradiotherapy, continue with GX chemotherapy.
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After 3 cycles of GX chemotherapy, capecitabine is taken orally simultaneously with radiotherapy.
After concurrent chemoradiotherapy, continue with GX chemotherapy.
Radiotherapy target and dose: Tumor bed, anastomosis, adjacent lymphatic drainage area :50 Gy; R1 resection area: 60 Gy; R2 resection area: 66-70 Gy (silver clip position), once daily.
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Actieve vergelijker: GX group
Gemcitabine and Capecitabine, repeated every 21 days as one cycle.
Administration for 6 cycles.
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Gemcitabine (G): Intravenous infusion of 1000 mg/m2 for more than 30 minutes, administered on day 1 and day 8, repeated every 21 days.
Capecitabine (X): 1660-2000mg/m2 per day, taken orally in two divided doses, from day 1 to day 14, repeated every 21 days as one cycle.
Administration for 6 cycles, every 3 weeks .
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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DFS
Tijdsspanne: From date of randomization until the first tumor recurrence, metastasis or death of the subject for any reason (whichever occurs first) assessed up to 24 months
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Defined as the time from random assignment to the first tumor recurrence, metastasis or death of the subject for any reason (whichever occurs first)
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From date of randomization until the first tumor recurrence, metastasis or death of the subject for any reason (whichever occurs first) assessed up to 24 months
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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OS
Tijdsspanne: From date of randomization until death from any cause or last follow-up, assessed up to 24 months
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The time from random assignment to death due to any cause.
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From date of randomization until death from any cause or last follow-up, assessed up to 24 months
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
22 mei 2026
Primaire voltooiing (Geschat)
1 mei 2029
Studie voltooiing (Geschat)
1 mei 2031
Studieregistratiedata
Eerst ingediend
21 mei 2026
Eerst ingediend dat voldeed aan de QC-criteria
4 juni 2026
Eerst geplaatst (Werkelijk)
8 juni 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
8 juni 2026
Laatste update ingediend die voldeed aan QC-criteria
4 juni 2026
Laatst geverifieerd
1 mei 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Endocriene systeemziekten
- Neoplasmata per site
- Neoplasmata
- Neoplasmata van het spijsverteringsstelsel
- Ziekten van het spijsverteringsstelsel
- Endocriene klierneoplasmata
- Alvleesklier Ziekten
- Pancreasneoplasmata
- Therapeutica
- Hydrolasen
- Enzymen
- Enzymen en co -enzymen
- Carbonylische esterhydrolasen
- Esterasen
- Phospholipases A2, Secretory
- Phospholipases A2
- Phospholipases A
- Phospholipases
- Radiotherapie
- Group X Phospholipases A2
Andere studie-ID-nummers
- E20260551
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .