A study comparing treatment with immunotherapy and chemotherapy before surgery against direct surgery, in patients with cancer of the mouth that can be operated on

A Phase III Randomized Controlled Trial Evaluating Perioperative Chemoimmunotherapy with Serplulimab, Paclitaxel, and Carboplatin Versus Upfront Surgery in Resectable Oral Cavity Squamous Cell Carcinoma

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/06/112961

Enrollment

522

Registered

2026-06-17

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-22

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: C039- Malignant neoplasm of gum, unspecified Health Condition 3: C069- Malignant neoplasm of mouth, unspecified Health Condition 4: C059- Malignant neoplasm of palate, unspecified Health Condition 5: C029- Malignant neoplasm of tongue, unspecified

Interventions

Intervention1: IMMNUNOTHERAPY WITH CHEMOTHERAPY: Neoadjuvant treatment with serplulimab (an anti PD-1 antibody) together with weekly paclitaxel and carboplatin duration 3-4 months Control Intervention

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age 18 to 75 years. 2. ECOG performance status 0 to 2. 3. Histologically confirmed oral cavity squamous cell carcinoma (OCSCC). 4. Clinical stage AJCC 8th edition Stage 3, Stage 4A, or Stage 4B locally advanced OCSCC (T1 to T2 with N1 to N2, or T3 to T4b with N0 to N3). 5. Resectable disease with intent for curative surgery. 6. Adequate organ function and no contraindications to immunotherapy or chemotherapy. 7. Normal organ and marrow function, defined as: leukocytes at least 3000 per microlitre; haemoglobin more than 8 g per dL; platelets at least 100000 per microlitre; total bilirubin up to 1.5 times the institutional upper limit of normal; AST (SGOT) and ALT (SGPT) up to 1.5 times the institutional upper limit of normal; calculated creatinine clearance more than 30 mL per minute. 8. Willing and able to comply with all study requirements. 9. Able to understand and willing to sign a written informed consent document.

Exclusion criteria

Exclusion criteria: 1. Primary oropharyngeal or laryngopharyngeal carcinoma, sinonasal cancers, or salivary gland tumours. 2. Clinical stage AJCC 8th edition Stage 1 or Stage 2 disease. 3. Prior chemoradiation to the head and neck region. 4. Known hypersensitivity to any of the study agents. 5. Pregnant or breastfeeding women. 6. HIV infection, active Hepatitis B infection, or active Hepatitis C infection. 7. Active, known, or suspected autoimmune disease. Participants with vitiligo, type 1 diabetes mellitus, residual hypothyroidism due to autoimmune conditions requiring only hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enrol. 8. Prior organ or stem cell transplant. 9. Condition requiring systemic treatment with either corticosteroids (more than 10 mg daily prednisone equivalent) or other immunosuppressive medication within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses of up to 10 mg daily prednisone equivalent are permitted in the absence of active autoimmune disease.

Design outcomes

Primary

Measure	Time frame
Event free survivalTimepoint: 3 years, at time of disease progression, recurrence or death	—

Secondary

Measure	Time frame
Overall survival (OS) time from randomisation to death from any cause, compared between arms. Timepoint: Timepoint: from randomisation; analysed at 3 years and at final analysis.	—

Countries

India

Contacts

Public ContactBurhanuddin Qayyumi

Homi Bhabha Cancer Hospital and Research Centre

qburhan@gmail.com9566170436

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 29, 2026