The Annals of Internal Medicine

LB Wright; Brook Mn

doi:10.52338/taoim

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The Annals of Internal Medicine

LB Wright, Brook Mn

Unknown Journal (2025)

Empirical-ClinicalCaseReportPDF AvailableGrade Eligible⚠️ Moderate Risk Flags

Overall Assessment

Weak Methodological Quality

Assessment created by PaperScorers Medical AI v0.1.0 on Dec 21, 2025

F

25/100

Key Takeaways

•Descriptive single-case of metastatic pancreatic cancer with durable remission.
•Precision neoantigen DC vaccination combined with chemotherapy and low-dose ICIs.
•CA19-9 normalised within 5 months; imaging clearance; pathologic CR post-resection.
•No data/materials shared; potential undeclared financial COI risk remains.

Conclusion

A rare, hypothesis-generating case; impressive outcome but very low evidential strength and limited reproducibility.

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Quality Dimensions

Bias & Integrity

COI handling, outcome switching, selective reporting

D40

Methods Rigour

Protocol clarity, sampling, controls

F28

External Validity

Generalisability, setting, population

F12

Transparency & Reproducibility

Data/code/materials availability, preregistration

F20

Significance & Novelty

Contribution vs prior art; context if known

C60

Statistical Validity

Models, assumptions, multiplicity, CI priority

F8

Integrity & Transparency

Integrity checks

P-hacking risk?

?

None suspected

Signs of selective hypothesis testing or analysis choices that could inflate false positive rates.

Outcome switching?

?

None suspected

Evidence that primary outcomes were changed during or after the study, potentially distorting results.

Conflict of interest?

?

Review recommended

Authors have financial or other relationships that could bias research findings.

Data integrity issues?

?

None suspected

Concerns about the accuracy, completeness, or authenticity of the reported data.

Open science signals

Research data

?

Not shared

Raw data used in the analyses is publicly available or accessible upon request.

Analysis code

?

Not shared

Code or scripts used to analyze the data are shared for reproducibility.

Study materials

?

Not shared

Protocols, questionnaires, and other materials are publicly available.

Premise

Primary Research Question

Can precision neoantigen DC vaccination plus chemotherapy achieve durable complete remission in metastatic pancreatic cancer?

Hypothesis is Falsifiable

✗No

Case report lacks pre-specified, testable hypothesis and comparator.

PICO Framework

Population✓Yes

63-year-old woman with stage IV pancreatic body/tail cancer and liver mets.

Intervention✓Yes

GEM+nab-PTX then FOLFIRINOX (oxaliplatin removed), DC vaccines, low-dose PD-1/CTLA-4, T cells.

Comparison—Not specified

No control/comparator in a single-case design.

Outcome✓Yes

CA19-9 normalisation; CT disappearance; pathological complete remission.

Literature Positioning

Literature Review Balanced

Well covered

Cites key chemo trials and neoantigen vaccine studies to frame context.

Evidence: References 1–7

Research Gap Clearly Stated

Well covered

Notes poor prognosis and emerging promise of genomic/immunotherapy.

Evidence: Introduction, p. 01

Stated Contribution Clear

Well covered

Reports complete pathological remission after precision immunochemotherapy.

Evidence: Abstract, p. 01; Results, Fig.1C

Study Provenance

Peer review unclearFunding not reportedNo conflicts declared7 affiliations listed

Authors & Affiliations

Premiere Clinic; Hanzoumon Ichou Clinic; Tokyo Medical University (Gastroenterology/Hepatology; GI & Paediatric Surgery); Juntendo University (Esophageal & Gastroenterological Surgery); Okabe Clinic, Tokyo.

Funding Statement

Not reported

Conflicts of Interest

The authors report that there are no competing interests to declare.

Peer Review

?Dates for received/reviewed/published listed; peer-review process not described.

Evidence: p. 01

Methodological Assessment

All design modules are marked as not applicable. Use the accordion below to review their details.

Modules without applicable checklist items (10)

These designs were fully marked as not applicable but remain available for reference.

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Study Overview

Study Design

Case Report

Primary classification used to evaluate this research.

Population

Single 63-year-old woman with pancreatic body/tail adenocarcinoma with squamous differentiation and multiple liver metastases (segments 4–6).

Brief summary of who or what was studied.

Sample Size

1

Number of participants included in the study analyses.

Study Arms

1 arm

Total number of intervention or comparison groups.

Pre-registration

Not registered

Indicates whether the protocol or trial was registered before data collection.

Follow-up

3 years 7 months

Duration of observation or follow-up for outcomes.

Primary Outcome

Primary outcome was not pre-specified.

Reviewer Notes

Single-patient case report; descriptive clinical course without control or inferential statistics.

Publication Details

DOI

10.52338/taoim

Published

June 10, 2025

Citations

133 citations

External Resources

DOI Link OpenAlex

Disclaimer: This assessment is generated by AI and should not be the sole basis for clinical or research decisions. Always review the original paper and consult with domain experts.

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