A Phase 2 interventional study of Capecitabine and Hydroxychloroquine in Pancreatic Cancer, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-05.
Sponsored by Massachusetts General Hospital · Phase 2, Interventional, and Treatment
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.
Subjects will be treated in cycles of 28 days. Hydroxychloroquine will be taken orally, daily until the day before surgery and will resume after surgery until study end.
Capecitabine will be taken orally, daily. Proton or photon radiation treatment will start on Week 2 and will be delivered daily (5 days in a row, but not weekends or holidays). Radiation treatment will be give on an outpatient basis at the Francis H. Burr Proton Center or the Clark Center for Radiation Oncology at Massachusetts General Hospital.
The following tests will be performed weekly: physical exam, routine blood tests, optional blood tests and an eye exam every 3 months while taking hydroxychloroquine.
Subjects will have surgery (any time between Weeks 5 to 9) and after surgery resume taking hydroxychloroquine. Subjects will have a follow up visit every 3 months which will include: physical exam, routine blood tests, eye exam, and tumor assessment by chest and abdominal-pelvic CT scan or MRI (every 6 months for the first 2 years and yearly for years 3-5).
3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.
This study's enrollment of 50 is close to the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.
Browse Pancreatic Neoplasms studies →Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Hydroxychloroquine with chemoradiation
Drug: Capecitabine · Drug: Hydroxychloroquine · Radiation: Proton or Photon Radiation Therapy
825 mg/m2 BID orally for a total of 10 days (M-F of weeks 2 and 3)
Also known as: Xeloda
400 mg BID from study day 1 until surgery. Dosing resumed upon discharge from hospital
Also known as: Plaquenil
Daily, beginning Week 2 for 5 consecutive days
Progression-free Survival
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.
Time frame: up to 4 years
Number of Participants With Pathologic Complete Response
Pathological complete response (pCR) will be defined as the absence of any viable tumor cells within the tissue samples removed during surgery.
Time frame: up to 9 weeks
Overall Survival
Overall survival (OS) is defined as the time from start of study therapy to date of death and will be reported as the number of patients alive after 2 years and 4 years on study. Participants who have not died will be censored at the date they were last known to be alive.
Time frame: up to 4 years
Treatment-Emergent Adverse Events
Treatment-emergent adverse events (TEAEs) are grade 3 or higher AEs as assessed by the CTEP Active Version of the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4, and at least possibly related to study treatment capecitabine + hydroxychloroquine and short course radiation therapy. TEAEs are AEs that began after the start of study treatment; or if the event was continuous from baseline and was serious, at least possibly related to study treatment, or resulted in death, discontinuation, or interruption or reduction of study treatment. Participants with multiple occurrences of TEAEs are counted only once per specific category in CTCAE v4.
Time frame: 3 weeks
Number of Participants With Surgical Morbidity
Surgical morbidity is defined as adverse events during an operation and up to 30 days afterwards, grade 3 or higher and at least possibly related to surgery as assessed by the CTEP Active Version of the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.
Time frame: up to 30 days after surgery
Number of Participants With Post-operative Mortality
Post-operative mortality is defined as death within 30 days after surgery.
Time frame: 30 days after surgery
Number of Participants With Pathologic Downstaging
Pathologic downstaging (pDS) is defined as a change in the tumor stage from pre-treatment clinical staging to the final pathology of the surgically removed tumor after receiving neoadjuvant treatment (i.e., treatment given before surgery).
Time frame: up to 9 weeks
Number of Participants With Local Control
Local control is defined as the time from the start of study treatment to the date of local failure; this outcome is reported below as the number of participants without local failure at 2 years after start of study treatment. Local failure is defined as progressive disease (PD) of the main tumor or at the margins of where the main tumor was surgically removed, as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) criteria v1.1 below: * At least a 20% increase in the longest diameter of target tumor lesion and an absolute increase of at least 5 mm, taking as reference the baseline measurement. * The appearance of one or more new lesions is also considered progression. Patients who have not experienced a local failure will be censored at the last date they were known to have local control.
Time frame: Up to 2 years
| Milestone | Hydroxychloroquine |
|---|---|
| Started | 50 |
| Completed | 50 |
| Not completed | 0 |
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.
| Participants | Hydroxychloroquine |
|---|---|
| 2-year PFS | 16 |
| 4-year PFS | 10 |
Pathological complete response (pCR) will be defined as the absence of any viable tumor cells within the tissue samples removed during surgery.
| Participants | Hydroxychloroquine |
|---|---|
| Number of Participants With Pathologic Complete Response | 1 |
Overall survival (OS) is defined as the time from start of study therapy to date of death and will be reported as the number of patients alive after 2 years and 4 years on study. Participants who have not died will be censored at the date they were last known to be alive.
| Participants | Hydroxychloroquine |
|---|---|
| 2-year OS | 21 |
| 4-year OS | 12 |
Treatment-emergent adverse events (TEAEs) are grade 3 or higher AEs as assessed by the CTEP Active Version of the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4, and at least possibly related to study treatment capecitabine + hydroxychloroquine and short course radiation therapy. TEAEs are AEs that began after the start of study treatment; or if the event was continuous from baseline and was serious, at least possibly related to study treatment, or resulted in death, discontinuation, or interruption or reduction of study treatment. Participants with multiple occurrences of TEAEs are counted only once per specific category in CTCAE v4.
| Participants | Hydroxychloroquine |
|---|---|
| Vomiting | 1 |
| Nausea | 1 |
| Hyperglycemia | 2 |
Surgical morbidity is defined as adverse events during an operation and up to 30 days afterwards, grade 3 or higher and at least possibly related to surgery as assessed by the CTEP Active Version of the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.
| Participants | Hydroxychloroquine |
|---|---|
| Number of Participants With Surgical Morbidity | 6 |
Post-operative mortality is defined as death within 30 days after surgery.
| Participants | Hydroxychloroquine |
|---|---|
| Number of Participants With Post-operative Mortality | 0 |
Pathologic downstaging (pDS) is defined as a change in the tumor stage from pre-treatment clinical staging to the final pathology of the surgically removed tumor after receiving neoadjuvant treatment (i.e., treatment given before surgery).
| Participants | Hydroxychloroquine |
|---|---|
| Number of Participants With Pathologic Downstaging | 47 |
Local control is defined as the time from the start of study treatment to the date of local failure; this outcome is reported below as the number of participants without local failure at 2 years after start of study treatment. Local failure is defined as progressive disease (PD) of the main tumor or at the margins of where the main tumor was surgically removed, as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) criteria v1.1 below: * At least a 20% increase in the longest diameter of target tumor lesion and an absolute increase of at least 5 mm, taking as reference the baseline measurement. * The appearance of one or more new lesions is also considered progression. Patients who have not experienced a local failure will be censored at the last date they were known to have local control.
| Participants | Hydroxychloroquine |
|---|---|
| Number of Participants With Local Control | 43 |
Collected over Up to 5 years. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Hydroxychloroquine | 39/50 (78%) | 20/50 (40%) | 50/50 (100%) |
| Event | Hydroxychloroquine |
|---|---|
| SepsisInfections and infestations | 7/50 |
| HypotensionVascular disorders | 6/50 |
| Respiratory failureRespiratory, thoracic and mediastinal disorders | 4/50 |
| Lymphocyte count decreasedInvestigations | 4/50 |
| Death NOSGeneral disorders | 3/50 |
| Intraoperative venous injuryInjury, poisoning and procedural complications | 2/50 |
| Myocardial infarctionCardiac disorders | 1/50 |
| FeverGeneral disorders | 1/50 |
| AspirationRespiratory, thoracic and mediastinal disorders | 1/50 |
| Wound infectionInjury, poisoning and procedural complications | 1/50 |
| Event | Hydroxychloroquine |
|---|---|
| FatigueGeneral disorders | 49/50 |
| NauseaGastrointestinal disorders | 47/50 |
| AnorexiaMetabolism and nutrition disorders | 44/50 |
| Abdominal painGastrointestinal disorders | 43/50 |
| DiarrheaGastrointestinal disorders | 41/50 |
| Weight lossInvestigations | 40/50 |
| ConstipationGastrointestinal disorders | 32/50 |
| VomitingGastrointestinal disorders | 31/50 |
| Back painMusculoskeletal and connective tissue disorders | 24/50 |
| FeverGeneral disorders | 22/50 |
| Age, Customized(Participants) | Hydroxychloroquine |
|---|---|
| Between 50-59 years | 8 |
| Between 60-69 years | 18 |
| Between 70-79 years | 20 |
| Between 80-89 years | 4 |
| Sex: Female, Male(Participants) | Hydroxychloroquine |
|---|---|
| Female | 24 |
| Male | 26 |
| Ethnicity (NIH/OMB)(Participants) | Hydroxychloroquine |
|---|---|
| Hispanic or Latino | 2 |
| Not Hispanic or Latino | 46 |
| Unknown or Not Reported | 2 |
| Race (NIH/OMB)(Participants) | Hydroxychloroquine |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 47 |
| More than one race | 0 |
| Unknown or Not Reported | 2 |
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