Adjuvant Chemoradiotherapy Versus Chemotherapy for Post-operative Pancreatic Cancer

Trial ID: NCT06427447

Interventional - Phase 3 - Recruiting

In this trial, we aim to compare the outcomes of adjuvant chemoradiotherapy with chemotherapy for patients with resected pancreatic cancer who are at high risk of disease progressions.

Conditions

• Pancreatic Cancer

Interventions

• Adjuvant chemoradiotherapy
• Adjuvant chemotherapy

Eligibility

Inclusion criteria

• No history of cancer treatment after surgical resection
• No disease progression confirmed by imaging examinations
• ECOG 0 to1 point
• No abnormality in blood routine test, liver and kidney function test and coagulation test (White blood cell count ≥4.0×10\^9/L, neutrophil count ≥2.0×10\^9, hemoglobin level ≥100g/L, platelet count ≥100×10\^9/L, ALT and AST level \< 2.5 times the upper limit of normal, total bilirubin and creatinine level within the normal, international normalized ratio \<2)
• Aged 18-75 years
• Pathologically confirmed pancreatic ductal adenocarcinoma
• Pathologically confirmed lymph node metastasis, R1 or R2 resection or lymphovascular invasion (one of the risk factors)

Exclusion criteria

• History of cancer treatment after surgical resection
• History of other cancers within 5 years
• Disease progression, including local pprogression or metastasis, confirmed by imaging examinations
• ECOG ≥2 points
• Significant abnormality in blood routine test, liver and kidney function test and coagulation test
• Active inflammatory bowel disease
• Gastrointestinal bleeding or perforation within 6 months
• Infections requiring antibiotics
• Heart or respirotory insufficiency
• Pregnant women or breastfeeding women

Sponsor

Changhai Hospital

Source: ClinicalTrials.gov

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