- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07632118
Radiotherapy With GX Regimen as Adjuvant Therapy for High-risk Patients Following Pancreatic Cancer Surgery
4. juni 2026 opdateret af: 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.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
288
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Maobin Meng
- Telefonnummer: 022-23340123-1111
- E-mail: mmeng@tmu.edu.cn
Studiesteder
-
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Tianjin Municipality
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Tianjin, Tianjin Municipality, Kina, 300060
- Rekruttering
- Tianjin medical university hospital and institute
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Ledende efterforsker:
- Jihui Hao
-
Kontakt:
- Maobin Meng
- Telefonnummer: (022)23340123-6417
- E-mail: mmeng@tmu.edu.cn
-
Underforsker:
- Maobin Meng
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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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Aktiv komparator: 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 .
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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DFS
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
OS
Tidsramme: From date of randomization until death from any cause or last follow-up, assessed up to 24 months
|
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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
22. maj 2026
Primær færdiggørelse (Anslået)
1. maj 2029
Studieafslutning (Anslået)
1. maj 2031
Datoer for studieregistrering
Først indsendt
21. maj 2026
Først indsendt, der opfyldte QC-kriterier
4. juni 2026
Først opslået (Faktiske)
8. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
8. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
4. juni 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Sygdomme i det endokrine system
- Neoplasmer efter sted
- Neoplasmer
- Neoplasmer i fordøjelsessystemet
- Sygdomme i fordøjelsessystemet
- Neoplasmer i endokrine kirtler
- Pancreassygdomme
- Bugspytkirtel neoplasmer
- Terapeutik
- Hydrolaser
- Enzymer
- Enzymer og coenzymer
- Carboxyliske esterhydrolaser
- Esteraser
- Phospholipases A2, Secretory
- Phospholipases A2
- Phospholipases A
- Phospholipases
- Strålebehandling
- Group X Phospholipases A2
Andre undersøgelses-id-numre
- E20260551
Plan for individuelle deltagerdata (IPD)
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