CLINICAL TRIAL / NCT04107077
Phase II Study of the Effects of Laparoscopic Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Patients With Advanced Gastric Cancer
- Interventional
- Recruiting
- NCT04107077
Contact Information
A Phase IIa Study of Laparoscopic Hyperthermic Intraperitoneal Chemotherapy (HIPEC) and PD-L1 Expression in Gastric Cancer With Peritoneal Metastases
To assess if PD-L1 expression can be upregulated in peritoneal metastases from gastric cancer after the administration of HIPEC with greater frequency compared to systemic chemotherapy alone
Gender
All
Age Group
18 Years and up
Accepting Healthy Volunteers
No
Inclusion Criteria:
- Patients with histologically confirmed GC/PM only and/or positive peritoneal
cytology, who have completed prior systemic chemotherapy for a minimum of 2 to 4
months duration.
- Age ≥18 years. Because no dosing or adverse event data are currently available on
the use of HIPEC for GC/PM in patients under 18 years of age, children are excluded
from this study, but will be eligible for future pediatric trials.
- ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A).
- Patients must have adequate organ and marrow function as defined below:
- leukocytes ≥3,000/mcL
- absolute neutrophil count ≥1,500/mcL
- platelets ≥100,000/mcL
- total bilirubin ≤ institutional upper limit of normal (ULN)
- AST(SGOT)/ALT(SGPT) ≤3 × institutional ULN
- creatinine ≤ institutional ULN OR
- glomerular filtration rate (GFR) ≥50 mL/min/1.73 m2 unless data exists
supporting safe use at lower kidney function values, no lower than 30
mL/min/1.73 m2 (see Appendix B).
- Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral
therapy with undetectable viral load within 6 months are eligible for this trial.
- For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV
viral load must be undetectable on suppressive therapy, if indicated.
- Patients with a history of hepatitis C virus (HCV) infection must have been treated
and cured. For patients with HCV infection who are currently on treatment, they are
eligible if they have an undetectable HCV viral load.
- Patients with a prior or concurrent malignancy whose natural history or treatment
does not have the potential to interfere with the safety or efficacy assessment of
the investigational regimen are eligible for this trial.
- Patients with known history or current symptoms of cardiac disease, or history of
treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac
function using the New York Heart Association Functional Classification. To be
eligible for this trial, patients should be class 2B or better.
- Expected survival greater than 3 months.
- Because cisplatin and Mitomycin C are pregnancy category D and potentially
teratogenic, women of child-bearing potential and men must agree to use adequate
contraception (hormonal or barrier method of birth control; abstinence) prior to
study entry and for the duration of study participation. Should a woman become
pregnant or suspect she is pregnant while she or her partner is participating in
this study, she should inform her treating physician immediately. Men treated or
enrolled on this protocol must also agree to use adequate contraception prior to the
study, for the duration of study participation, and 4 months after completion of the
study.
- Ability to understand and the willingness to sign a written informed consent
document.
Exclusion Criteria:
- Patients with coexistence of another untreated malignant neoplasm other than basal
cell carcinoma of the skin within the last five years.
- Sites of metastases other than loco-regional lymph nodes and peritoneum (ex.
Visceral metastases such as liver, lungs, bone, brain).
- Patients who have not recovered from adverse events due to prior anti-cancer therapy
(i.e., have residual toxicities > Grade 1) with the exception of alopecia.
- Patients who are receiving any other investigational agents.
- History of allergic reactions attributed to compounds of similar chemical or
biologic composition to cisplatin and Mitomycin C.
- Patients with uncontrolled intercurrent illness.
- Patients with psychiatric illness/social situations that would limit compliance with
study requirements.
- Pregnant women are excluded from this study because cisplatin and Mitomycin C are
class D agents with the potential for teratogenic or abortifacient effects. Because
there is an unknown but potential risk for adverse events in nursing infants
secondary to treatment of the mother with cisplatin and Mitomycin C, breastfeeding
should be discontinued if the mother is treated with cisplatin and Mitomycin C.