To Evaluate the Treatment Outcome with Addition of Nonavalent HPV Vaccination to Chemoradiotherapy in Cervical Cancer

Evaluating the Clinical and Molecular Outcomes with Addition of Nonavalent HPV Vaccination to Chemoradiotherapy in Locally Advanced Cervical Cancer: A Pilot Phase II Open Label Randomized Controlled Trial - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/08/093834

Enrollment

Registered

2025-08-28

Start date

Unknown

Completion date

Unknown

Last updated

2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C539- Malignant neoplasm of cervix uteri, unspecified

Interventions

Intervention1: Intervention Arm (CRT + HPV Vaccine): Same as Control + 3 intramuscular doses of nonavalent HPV vaccine (Day 1, Month 2, Month 6) Control Intervention1: Control Arm (CRT): External beam

Eligibility

Inclusion criteria

Inclusion criteria: 1. Histopathologically confirmed squamous, adeno and adenosquamous carcinoma cervix patients 2. Age group 18 to 45 years 3. Eastern Cooperative Oncology Group (ECOG) score of less than or equal to 2 4. Clinical FIGO stage IB3 to IIIB 5. No or controlled comorbidities 6. Normal hematological and biochemical parameters i.e. normal liver and kidney function test (GFR more than 60ml per minute AST less than 2.5 ULN and S. Bilirubin less than 1.5 ULN) with normal hemogram values (absolute neutrophil count more than 2000 per dl, white blood cell count more than 4000 per dl, platelets more than 100000 per dl, hemoglobin Hb more than 10 g per dl) 7. Adequate cardiac function, measured as Ejection fraction more than 55% 8. Normal Pure Tone Audiometry (PTA) 9 The patient must be able to understand and follow instructions and must be able to participate in the study for the entire period. Written valid informed consent prior to treatment is a must

Exclusion criteria

Exclusion criteria: 1. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 3-4 2. Previous radiotherapy to abdomen or pelvis or previous chemotherapy 3. FIGO Stage IIIC1, IIIC2, IVA and IVB 4. Synchronous malignancy at any other site or any other malignancy in the past five years 5. Any uncontrolled comorbidity which may compromise delivery of protocol defined chemotherapy and radiotherapy e.g., renal disease, cardio-respiratory disease, diabetes mellitus, Pregnancy 6. Connective tissue disorder (e.g., Scleroderma, SLE) 7. Not able to tolerate cisplatin

Design outcomes

Primary

Measure	Time frame
Tumor responseTimepoint: 3 months post-treatment	—

Secondary

Measure	Time frame
Progression free survivalTimepoint: 12 months;HPV cfDNA copy numberTimepoint: Baseline, 3 and 12months;QoL ScoresTimepoint: Baseline, 3 and 12months	—

Countries

India

Contacts

Public ContactDr Abhishek Shankar

All India Institute of Medical Sciences Delhi

Priyadhana07@gmail.com6385456381

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026