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Benefits of Low Dose Nivolumab Plus Triple Metronomic Chemotherapy in Advanced Head & Neck Cancer

Low Dose Nivolumab plus Triple Metronomic Chemotherapy in Advanced head &neck cancer - A Single Centre Study From Eastern India - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2023/10/059116
Enrollment
45
Registered
2023-10-26
Start date
Unknown
Completion date
Unknown
Last updated
2023-11-13

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

Conditions

Health Condition 1: C049- Malignant neoplasm of floor of mouth, unspecified Health Condition 2: C009- Malignant neoplasm of lip, unspecified Health Condition 3: C069- Malignant neoplasm of mouth, unspecified Health Condition 4: C109- Malignant neoplasm of oropharynx,unspecified Health Condition 5: C148- Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx Health Condition 6: C029- Malignant neoplasm of tongue, unspecified

Interventions

Intervention1: NIL: NIL

Sponsors

Dr Santosh Kumar Swain
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adults with advanced HNSCC 2. With an Eastern Cooperative Oncology Group performance status of 0-2 3. Who were planned for palliative systemic therapy 4. With normal organ function 5. At least one measurable lesion. 6. Biopsy proven 7. Inoperable and metastatic 8. Platinum sensitive and refractory as well.

Exclusion criteria

Exclusion criteria: 1. Patients less than 18 years of age 2. Patients not meeting the above-mentioned criteria 3. Patients or patient relatives who do not consent 4. Pregnant and lactating females. 5. Patients on any other investigational agent(s) 6. Patients with autoimmune disease 7. Patients receiving immunosuppressants 8. Patients with uncontrolled comorbidities

Design outcomes

Primary

MeasureTime frame
To evaluate progression free survival(PFS) with low dose Nivolumab plus TMC (Methotrexate, Erlotinib, Celecoxib) in new or recurrent metastatic Head & Neck squamous cell carcinoma(HNSCC).Timepoint: 3 monthly—

Secondary

MeasureTime frame
1. To assess overall survival(OS) with low dose Nivolumab plus TMC. 2. To determine the Response rate of low dose Nivolumab plus TMC. 3. To evaluate the toxicity of low dose Nivolumab plus TMC. Timepoint: 3 monthly—

Countries

India

Contacts

Public ContactDr Ghanashyam Biswas

Institute of Medical sciences and SUM Hospital

drgbiswas@gmail.com8895370579

Outcome results

None listed

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