NCT06427447 Adjuvant Chemoradiotherapy Versus Chemotherapy for Pancreatic Cancer (ADJUPANC)
| NCT ID | NCT06427447 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Changhai Hospital |
| Condition | Pancreatic Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 770 participants |
| Start Date | 2024-08-06 |
| Primary Completion | 2028-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 770 participants in total. It began in 2024-08-06 with a primary completion date of 2028-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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) * 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) 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
Contact & Investigator
Huojun Zhang, M.D.
PRINCIPAL INVESTIGATOR
Changhai Hospital
Frequently Asked Questions
Who can join the NCT06427447 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Pancreatic Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06427447 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 770 participants.
Is NCT06427447 currently recruiting?
Yes, NCT06427447 is actively recruiting participants. Contact the research team at zhuxiaofei_zxf@163.com for enrollment information.
Where is the NCT06427447 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06427447 clinical trial?
NCT06427447 is sponsored by Changhai Hospital. The principal investigator is Huojun Zhang, M.D. at Changhai Hospital. The trial plans to enroll 770 participants.
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