A randomized controlled trial comparing pre-operative Chemotherapy oral metronomic therapy and immunotherapy to pre-operative Immunotherapy alone in resectable oral cavity squamous cancer

A Phase II Randomized Trial of Neoadjuvant Chemo-Immunotherapy with Carboplatin, Nab- Paclitaxel, Oral Metronomic Chemotherapy, and Toripalimab vs Immunotherapy in Locally Advanced Operable Oral Cavity Squamous Cell Carcinoma (OCSCC) - NeoLOCUS-3

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/04/109386

Enrollment

102

Registered

2026-04-27

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-01

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

Conditions

Health Condition 1: C148- Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx

Interventions

Intervention1: Chemo-Immunotherapy with Carboplatin, Nab- Paclitaxel, Oral Metronomic Chemotherapy, and Toripalimab: Carboplatin AUC 5 + Nab Paclitaxel 175mg/m2 + OMCT (Tab. Methotrexate 9 mg/m2 once

Eligibility

Inclusion criteria

Inclusion criteria: Age 18 years or older ECOG performance status 0 to 2 Histologically confirmed oral cavity squamous cell carcinoma Non metastatic disease Resectable disease based on multidisciplinary tumor board decision Tumor site in oral cavity including tongue or buccal mucosa Stage III or IVA or IVB or T3 or T4 or node positive disease Stage II allowed only if tumor volume more than 8 cm3 Measurable disease by RECIST 1.1 Biopsy available from non irradiated site Adequate organ function Written informed consent obtained Participants willing to use contraception during study Female participant not pregnant or breastfeeding

Exclusion criteria

Exclusion criteria: Metastatic disease Inoperable disease Cancer outside oral cavity Prior treatment Drug allergy Severe cardiac disease Autoimmune disease Chronic liver disease Hepatitis B or HIV Pregnancy or lactation

Design outcomes

Primary

Measure	Time frame
Major pathological responseTimepoint: Post NeoAdjuvant Chemohemoterapy and Surgery	—

Secondary

Measure	Time frame
Event free survivalTimepoint: Up to 2 years;Overall survivalTimepoint: Up to 3 years;Pathological complete responseTimepoint: At surgery;Objective response rate by RECIST 1.1Timepoint: After neoadjuvant therapy (6 weeks);Grade 3 or higher adverse events (CTCAE v5.0)Timepoint: Up to 6 weeks;Rate of R0 resectionTimepoint: At surgery;Radiological response by volumetric assessmentTimepoint: After neoadjuvant therapy (6 weeks);Correlation of pathological response with survivalTimepoint: Up to 36 months;Presence of extranodal extension or positive marginsTimepoint: At surgery;Proportion receiving concurrent cisplatin during radiotherapyTimepoint: Post surgery;Adequate cumulative cisplatin dose achievedTimepoint: During adjuvant treatment;ypN0 rate and nodal downstagingTimepoint: At surgery;Perioperative complicationsTimepoint: Within 30 days after surgery;Radiotherapy initiation and complianceTimepoint: Post surgery;Reasons for cisplatin omission or discontinuationTimepoint: During adjuvant treatment	—

Measure

Time frame

Event free survivalTimepoint: Up to 2 years;Overall survivalTimepoint: Up to 3 years;Pathological complete responseTimepoint: At surgery;Objective response rate by RECIST 1.1Timepoint: After neoadjuvant therapy (6 weeks);Grade 3 or higher adverse events (CTCAE v5.0)Timepoint: Up to 6 weeks;Rate of R0 resectionTimepoint: At surgery;Radiological response by volumetric assessmentTimepoint: After neoadjuvant therapy (6 weeks);Correlation of pathological response with survivalTimepoint: Up to 36 months;Presence of extranodal extension or positive marginsTimepoint: At surgery;Proportion receiving concurrent cisplatin during radiotherapyTimepoint: Post surgery;Adequate cumulative cisplatin dose achievedTimepoint: During adjuvant treatment;ypN0 rate and nodal downstagingTimepoint: At surgery;Perioperative complicationsTimepoint: Within 30 days after surgery;Radiotherapy initiation and complianceTimepoint: Post surgery;Reasons for cisplatin omission or discontinuationTimepoint: During adjuvant treatment

—

Countries

India

Contacts

Public ContactAjoy Oommen John

Christian Medical College Vellore

ajoyoommenjohn@gmail.com7639195315

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026