Clinical trial · Interventional
Short Course Radiation Therapy With Proton or Photon Beam Capecitabine and Hydroxychloroquine for Resectable Pancreatic Cancer
Phase II Study of Neoadjuvant Accelerated Short Course Radiation Therapy With Proton or Photon RT Plus Capecitabine and Hydroxychloroquine for Resectable Pancreatic Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A standard treatment for patients with pancreatic cancer is standard photon radiation in combination with the chemotherapy drug, capecitabine. In this research study the investigators are using standard photon radiation or a different type of radiation therapy called proton beam radiation and adding hydroxychloroquine to be used in combination with capecitabine. In this research study, the investigators are looking to determine if proton or photon beam radiation in combination with hydroxychloroquine and capecitabine is effective in controlling your cancer growth.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| Hydroxychloroquine | Drug | Hydroxychloroquine | ALIAS |
| Proton or Photon Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Hydroxychloroquine
- description
- Hydroxychloroquine with chemoradiation
- interventionNames
- Drug: Capecitabine
- Drug: Hydroxychloroquine
- Radiation: Proton or Photon Radiation Therapy
Primary outcomes (1)
- measure
- Progression-free Survival
- timeFrame
- up to 4 years
- description
- Progression-free survival (PFS) will be defined as the time from the start of treatment until the first objective documentation of progressive disease (PD) per Response Evaluation Criteria in Solid Tumors (RECIST) criteria, or death. PFS is reported as the number of participants without PD after 2 years and 4 years on study. Participants who die without a reported prior progression will be considered to have progressed on the day of their death. Progressive disease (PD) is defined as at least a 20% increase in the sum of longest the diameters of target lesions, taking as reference the baseline sum diameters. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Cytologic or histologic proof of pancreatic ductal carcinoma * Life expectancy \> 3 months * Adequate organ and marrow function Exclusion Criteria: * Evidence of metastatic disease * Pregnant or breast-feeding * Tumors in the body or tail of the pancreas * Serious concomitant systemic disorders such as significant cardiac or pulmonary morbidity (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 12 months, ongoing infection as manifest by fever * Prior chemotherapy or radiation for treatment of the patient's pancreatic tumor * Diagnosis of other invasive carcinomas (except basal cell carcinomas/squamous cell carcinoma of the skin) with the last 5 years. Carcinoma in-situ is allowed. * Other serious uncontrolled medical conditions * Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome * Known, existing uncontrolled coagulopathy * Prior systemic fluoropyrimidine therapy (unless given in an adjuvant setting and completed at least 6 months earlier). Prior unanticipated severe reaction to fluoropyrimidine therapy, or known hypersensitivity to 5-fluorouracil or known DPD deficiency * Participation in any investigational drug study within 4 weeks preceding the start of study treatment * History of uncontrolled seizures, central nervous system disorders, or psychiatric disability * Major surgery, excluding laparoscopy, within 4 weeks of the start of study treatment, without complete recovery * Currently taking cimetidine * Receiving any other study agents * History of allergic reactions attributed to compounds of similar chemical or biologic composition to capecitabine and HCQ * Already taking HCQ or chloroquine for other diagnosis * History of Grade 3 or greater retinopathy or keratitis
References
Publications (0)
Data not yet available