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Chemotherapy plus immunotherapy in borderline resectable oral cavity cancer.

Low dose Nivolumab plus DCF(Docetaxel, Cisplatin, 5-Flourouracil) in Locally Advanced Technically Unresectable Oral Cavity Cancer A Single Centre Study From Eastern India. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/02/080046
Enrollment
50
Registered
2025-02-07
Start date
Unknown
Completion date
Unknown
Last updated
2025-03-03

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

Conditions

Health Condition 1: C01- Malignant neoplasm of base of tongue

Interventions

Intervention1: NIL: NIL

Sponsors

Department of Medical Oncology
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Biopsy-proven locally advanced oral cavity cancer with T4aN3b or T4bN3b Age above 18 years WithanEasternCooperativeOncologyGroupperformancestatusof 0-2 With normal cardiac, renal, hematologic, hepatic, and pulmonary function

Exclusion criteria

Exclusion criteria: Lesion of T4a/T4b with high ITF, base of skull and carotid sheath involvement. Pregnant and lactating females. Patients with uncontrolled DM/HTN Patients with autoimmune disease. Patients receiving immunosuppressants.

Design outcomes

Primary

MeasureTime frame
To determine Curative Resection Rate with DCF plus low dose nivolumab in locally advanced unresectable oral cavity cancer patients.Timepoint: Every 3 monthly—

Secondary

MeasureTime frame
To assess Response rate with DCF plus low dose nivolumab in locally advanced unresectable oral cavity cancer. To establish Progression Free Survival (PFS). To determine Overall Survival Rate. To evaluate toxicity profile. Timepoint: Every 3 monthly—

Countries

India

Contacts

Public ContactDr Akash Amruthrao Bhange

Institute of Medical sciences and SUM Hospital

drlalatendu@gmail.com9538752579

Outcome results

None listed

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