Retrospective Study on Anti-cancer Therapy for Gastric Cancer Patients Complicated With Bleeding
Conditions: Gastric Cancer
Sponsor: Peking University Third Hospital

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July 19, 2024
Protocal:
Retrospective study on anti-cancer systematic therapy for
gastric cancer patients complicated with bleeding

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Retrospective study on anti-cancer systematic therapy for gastric
cancer patients complicated with bleeding
Abstract
BACKGROUND
Hemorrhage isn’t a rare complication with gastric cancer (GC)/gastroesophageal
junction cancer (GEJC) and may lead to poor prognosis.
AIM
To investigate the impact of overt bleeding (OB) on the survival and treatment related
adverse events (TRAEs) of GC/GEJC patients.
METHODS
This study will retrospectively enroll advanced or metastatic GC/GEJC patients who
received systematic treatment at Peking University Third Hospital. The study aims to
investigate the impact of OB on TRAEs for GC/GEJC patients receiving anti-cancer
treatment, evaluate the risk factors of overt bleeding after treatment (OBAT), assess
the influence of overt bleeding on the overall survival (OS).
Key words: Gastric cancer (GC)/gastroesophageal junction cancer (GEJC), Overt
bleeding (OB), Systematic treatment
INTRODUCTION
Gastric cancer was the fifth most common cancer and ranked fourth for cancer
mortality worldwide in 2020[1]. Hemorrhage wasn’t a rare complication with gastric
cancer (GC)/gastroesophageal junction cancer (GEJC). About 15.7% of GC/GEJC
patients experienced bleeding[2]. Hemorrhage not only reduced the quality of life in
GC/GEJC patients, but also led to poor prognosis even life-threatening if it was
failure to timely stop and affected anti-cancer treatment[3, 4].
Risk factors for hemorrhage with GC/GEJC were various, including oldness,
smoking history, chronic disease, use of antithrombotic/anticoagulants and so on[2, 5].
Radical gastrectomy was an ideal for early stage GC/GEJC with overt bleeding (OB),

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but there was no curable chance for patients with advanced or metastatic GC/GEJC
and
hemostatic
strategies
such
as
endoscopic
therapy,
transcatheter
arterial
embolization were prone to rebleeding[4, 6, 7]. GC/GEJC patients with hemorrhage
were less likely to receive chemotherapy due to poor physical quality and concern
about treatment related adverse events (TRAEs) and rebleeding.
The retrospective study aims to investigate the impact of OB on TRAEs for
GC/GEJC patients receiving anti-cancer treatment, assess the influence of overt
bleeding on the overall survival (mOS).
PATIENTS AND METHODS
Data source and study patients
We will retrospectively enroll patients who were diagnosed with advanced or
metastatic GC/GEJC at department of medical oncology and radiation sickness of
Peking University third hospital. The elligibility criteria are as follows: 1) patients
older than 18 years. 2) a histologically confirmed diagnosis of advanced or metastatic
GC/GEJC. 3) the initial anti-cancer treatment was systematic therapy, including
chemotherapy, targeted therapy or immune checkpoint inhibitor (ICI). 4) no history of
gastrectomy
before
systematic
therapy.
The
exclusion
criteria
included:
1)
incompletable clinical data. 2) Siewert I type esophagus cancer.
The patients information collected from the database is as follows: age, gender,
height, weight, Eastern Corporative Oncology Group Performance Status (ECOG-PS),
chronic disease, drinking history, smoking history, diagnosis and metastatic sites,
primary tumor location, histological grade, clinical stage according to the 8th edition
of AJCC (American Joint Committee on Cancer) cancer staging manual, overt
bleeding, symptoms, therapy strategy, tumor response to treatment, objective response
rate (ORR), disease control rate (DCR), TRAEs and media overall survival (mOS).
Definitions
The diagnosis of OB is that the following conditions occurred one month before
systematic treatment: 1) melena, hematemesis or hematochezia caused by gastric
lesion, or 2) gastric hemorrhage confirmed by endoscopy. This study will only

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analyze the impact of gastric overt bleeding (not including occult bleeding) on
patients.
The radiographic best response to treatment will be assessed as complete response
(CR), partial response (PR), stable disease (SD), no CR or no progressive disease
(PD), or PD on the basis of response evaluation criteria in solid tumor 1.1 by
clinicians. Objective response rate (ORR) is defined as the proportion of patients with
the best response CR or PR. Disease control rate (DCR) is defined as the proportion
of patients whose best response was CR, PR, no CR or no PD, or SD. Patients will be
followed up at regular intervals. The criterion for terminating follow-up is death for
any reason. OS is defined as the time from the first cycle of systematic therapy to
death from any cause. TRAEs are evaluated according to the National Cancer Institute
Common Toxicity Criteria version 4.0.
Statistical analysis
We will use SPSS version 25.0 (International Business Machines, New York, United
States) to analyze the data and considered that differences are statistically significant
if the two-sided P values are less than 0.05. The classified variables will be assessed
by the χ2 test or Fisher’s exact test. A binary logistic regression model (entry method)
will be used to identify items independently associated with OBAT. Odds ratios (ORs)
and 95% confidence intervals (CIs) will be calculated. Survival curves will be
estimated by the Kaplan-Meier method with the log-rank test. Hazard ratios (HRs)
and 95%CIs will be calculated using the Cox proportional hazards model, and a check
on the assumption of proportional risk will be conducted.
CONCLUSION
In conclusion, this study aims to evaluate the efficacy and
safety of systematic
therapy on GC/GEJC patients with bleeding. We hope the study will provide basis for
future prospective clinical trial.

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Institutional review board statement: This study was approved by the Peking
University
Third
Hospital
Medical
Science
Research
Ethics
Committee
(IRB00006761-M2023544).
Informed consent statement: A waiver of informed consent was granted by the
Ethics Committee.
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