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Recruiting NCT06427447

Adjuvant Chemoradiotherapy Versus Chemotherapy for Pancreatic Cancer (ADJUPANC)

Phase III Interventional Pancreatic Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Adjuvant chemoradiotherapy, Adjuvant chemotherapy.
Who it may be relevant to
Registry conditions: Pancreatic Cancer. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Adjuvant Chemoradiotherapy Versus Chemotherapy for Post-operative Pancreatic Cancer

Overview

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.

Detailed description

Pancreatic cancer is a lethal malignancy with the lowest 5-year overall survival rate of 9% and an increasing incidence. In China, the mortality of pancreatic cancer ranked the sixth among all cancers. Although surgical resection is the only radical treatment, only less than 20% patients could receive upfront surgery at the initial diagnosis. Even though patients have surgery, the incidence of disease progressions, including local progression and metastasis, is about 80-90%. In NCCN guidelines and Chinese guidelines, adjuvant chemotherapy is recommended for post-operative pancreatic cancer, while adjuvant chemoradiotherapy could also be used. However, it has not been clarified that which patients may benefit from adjuvant chemoradiotherapy, and no high-level evidence has shown the advantages of adjuvant chemoradiotherapy over chemotherapy. In meta-analyses, it was demonstrated that patients with lymph nodes metastases, R1 or R2 resection or lymphovascular invasion could achieve longer survival after adjuvant chemoradiotherapy compared with chemotherapy. Therefore, we aim to compare the outcomes of adjuvant chemoradiotherapy with those of chemotherapy in patients with lymph nodes metastases, R1 or R2 resection or lymphovascular invasion after surgical resection of pancreatic cancer.

Interventions

  • Combination product Adjuvant chemoradiotherapy
    Upfront chemotherapy (gemcitabine plus capecitabine) followed chemoradiotherapy (radiotherapy with concurrent capecitabine)
  • Drug Adjuvant chemotherapy
    Chemotherapy (gemcitabine plus capecitabine)

Primary outcome measures

  • Disease progression free survival will be determined. [Time frame: 3 years]
Secondary outcome measures (3)
  • Overall survival will be determined. [Time frame: 3 years]
  • Treatment-related adverse events will be determined. [Time frame: 3 years]
  • Quality of life will be determined. [Time frame: 3 years]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Huojun Zhang — Shanghai

Publications

  • Zhu X, Liu W, Jiang L, Cao Y, Ye Y, Yu C, Yin X, Zhang H. ADJUPANC protocol: a phase III study of adjuvant chemotherapy versus chemoradiotherapy for pancreatic cancer. Future Oncol. 2025 Aug;21(18):2269-2273. doi: 10.1080/14796694.2025.2522061. Epub 2025 Jun 29. PMID 40583350

Identifiers

NCT: NCT06427447 · CH hospital

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗