Treatment for HPV-related oropharyngeal cancer using liquid biopsy

JRCT ID: jRCTs051240125

Registered date:18/09/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: HPV-associated oropharyngeal squamous cell carcinoma
• Date of first enrollment: 18/09/2024
• Target sample size: 40
• Study type: Interventional
• Intervention(s): Radiation therapy, chemotherapy

Outcome(s)

Primary Outcome

Complete molecular response rate
the proportion of patients who have negative results for ctHPVDNA at the time of 12 week post-radiation

Secondary Outcome

Complete metabolic response rate (the proportion of patients with no FDG at the time of 12 week post-radiation
intake at the tumor sites)
Progression free survival
Overall survival
Recurrence-free survival
Adverse events
QOL

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 85age old
• Gender: Both

Include criteria

1, histologically diagnosed squamous cell carcinoma of the oropharynx, p16 positive on immunostaining and HPV16 DNA positive by PCR
2, cT1-2 N1-2b M0 or cT3 N0-2b M0
3, detectable ctHPVDNA within 28 days prior to enrollment
4, performance status 0 or 1
5, measurable disease
6, no previous treatment for the current disease
7, no prior chemotherapy with platinum and no prior radiotherapy in the neck
8, no dysfunctional vital organs
blood test within 28 days prior to enrollment should be
a, neutrophil count of 1,500/mm3 or more
b, Hb of 10.0 g/dL or more
c, platelet count of 100 x 103/mm3 or more
d, total bilirubin of 1.5 mg/dL or less
e, AST of 100 U/L or less
f, ALT of 100 U/L or less
g, creatine clearance of 60 mL/min or more
9, age at consent to participate in this study should be 18 to 85 years old
10, life expectancy of more than 6 months at consent
11, consent can be obtained from the subject him or herself

Exclude criteria

1, active second primary malignancies
2, infectious disease requiring systemic therapy
3, body temperature of 38 Celsius degree or above at the time of enrollment
4, females with pregnant, possible pregnant, within 28 days after delivery, or under breast-feeding. males who want to have a child with his partner
5, mental disorders which may cause difficulties to participate in this trial
6, under treatment with corticosteroid or other immunosuppressive agents
7, serum HBs antigen positive
8, serum HIV antibody positive
9, current smoker
10, ctHPVDNA<10 copy/mL within 28 days prior to enrollment
11, ctHPVDNAof 5,000 copy/mL or more within 28 days prior to enrollment
12, intratumoral HPV DNA <2 copy/cell
13, anatomically unresectable disease
14, subjects whom doctors in charge considered ineligible for this study

Related Information

• Primary Sponsor: Inohara Hidenori