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A Study to Preserve Tongue Function Using Chemotherapy, Immunotherapy, and Radiation in Patients with Advanced Tongue Cancer

A phase II study for PREServing TOngue with Neoadjuvant chemoimmunotherapy and chemoradiation in advanced tongue cancers: PRESTO study - PRESTO

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/09/094454
Enrollment
45
Registered
2025-09-09
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: C029- Malignant neoplasm of tongue, unspecified

Interventions

Intervention1: Nivolumab 40mg: Nivolumab 40mg iv every 3 weekly will be given for 3 cycles along with the NACT Intervention2: CTRT: Patients who respond to chemoimmunotherapy,will be considered eligib

Sponsors

Tata Memorial Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Stage III/ Stage IV (AJCC 8th edition) Squamous Cell Carcinoma of Tongue 2. Upfront Resectable (as deemed by a DMG surgeon) 3. N stage: N0-N2c (AJCC 8th edition) 4. Requiring Major Glossectomy (Type IV/ Type V-Ansarin Classification) (22) 5. With CPS score more than equal to 1 on Bx (IHC)

Exclusion criteria

Exclusion criteria: 1.N3a/N3b tumors (AJCC 8th edition) 2.Unresectable at baseline 3.Recurrent Tumors 4.Having Received other cancer-directed treatment 5.Verrucous lesions

Design outcomes

Primary

MeasureTime frame
To assess the efficacy and safety of neoadjuvant chemoimmunotherapy and chemoradiation for tongue preservation in patients requiring a major glossectomyTimepoint: 1 year

Secondary

MeasureTime frame
To identify a subgroup of Indian oral cavity cancer patients who have a good response to Neoadjuvant chemoimmunotherapyTimepoint: 2.5 years

Countries

India

Contacts

Public ContactDr Shwetabh Sinha

TATA MEMORIAL HOSPITAL

shwetabhsinha23@gmail.com02224177262

Outcome results

None listed

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