Benmelstobart-Anlotinib-Chemo for Neoadjuvant Oral Cancer

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

26

Participants

Timeline

Start Date

June 15, 2025

Primary Completion Date

December 31, 2027

Study Completion Date

December 31, 2028

Conditions
Mouth NeoplasmsNeoadjuvant TherapyImmunotherapyMolecular Targeted Therapy
Interventions
DRUG

benmelstobart-Anlotinib-Chemo

"Neoadjuvant Treatment Regimen :~Benmelstobart: 1200mg, Day 1, IV (21 days per cycle); Anlotinib: 10mg, Days 1-14, orally (21 days per cycle); Cisplatin: 60mg/m², Day 1, IV (21 days per cycle); Albumin-bound Paclitaxel: 260mg/m², IV infusion, Day 1 (21 days per cycle). Total of 3 cycles.~Surgery is performed within 2 weeks after completing neoadjuvant therapy. Postoperative adjuvant treatment is selected based on pathological grading:~Group A (pCR): Postoperative RT alone: 40Gy/5 weeks. Group B (MPR): Postoperative RT alone: 50Gy/5 weeks. Group C (partial pathological response/no pathological response) : low and intermediate-risk patients: RT: 60Gy/6w; High-risk patients: CCRT: 60-66Gy/6-6.6w + cisplatin: 60mg/m2 Q3W, 2-3 cycles.~All patients also received adjuvant Benmelstobart 3-4 weeks after surgery, as well as maintenance Benmelstobart for a total duration of 1 year."

Trial Locations (1)

Unknown

Affiliated Stomatological Hospital of Nanjing Medical University, Nanjing

All Listed Sponsors
collaborator

Affiliated Stomatological Hospital of Nanjing Medical University

UNKNOWN

lead

Jiangsu Cancer Institute & Hospital

OTHER