Benmelstobart-Anlotinib-Chemo for Neoadjuvant Oral Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorJiangsu Cancer Institute & Hospital
About this trial
Exploring the Safety and Efficacy of Benmelstobart Combined with Anlotinib and Chemotherapy as Neoadjuvant Therapy Followed by Surgery and Postoperative Radiotherapy in Patients with Locally Advanced Oral Cancer
This is a single-center, Phase II study targeting patients with stage III-IVb locally advanced oral squamous cell carcinoma who meet the inclusion and exclusion criteria. The neoadjuvant therapy consists of Benmelstobart combined with Anlotinib and chemotherapy for 3 cycles (21 days per cycle). Surgery is performed within 2 weeks after completing neoadjuvant therapy. Postoperative adjuvant treatment is selected based on pathological grading:
Group A (Pathological Complete Response, pCR): Postoperative radiotherapy (RT) alone: 40Gy/5 weeks.
Group B (Major Pathological Response, MPR): Postoperative radiotherapy (RT) alone: 50Gy/5 weeks.
Group C (Partial Pathological Response/No Pathological Response):
Low-to-intermediate risk patients (no extracapsular nodal extension and negative margins): RT: 60Gy/6 weeks.
High-risk patients (extracapsular nodal extension and/or positive margins): Concurrent chemoradiotherapy (CCRT): 60-66Gy/6-6.6 weeks + Cisplatin: 60mg/m² every 3 weeks, 2-3 cycles.
Additionally, all patients will receive adjuvant Benmelstobart 3-4 weeks after surgery, followed by Benmelstobart maintenance therapy (total treatment duration of 1 year).
Eligibility criteria
Qualifiers
Age 18-75 years;
ECOG PS score of 0-1;
Pathologically confirmed untreated oral squamous cell carcinoma patients, classified as stage III-IVb according to the AJCC (8th edition) staging system;
Women of childbearing potential must have taken reliable contraceptive measures or have a negative pregnancy test (serum or urine) within 7 days prior to enrollment, and be willing to use appropriate contraceptive methods during the trial and for 8 weeks after the last dose of the study drug, or be surgically sterilized. For men, they must agree to use appropriate contraceptive methods during the trial and for 8 weeks after the last dose of the study drug, or be surgically sterilized;
Disqualifiers
Prior treatment with PD-1/PD-L1/CTLA-4 antibodies.
Tumor invasion of major blood vessels.
Requirement for systemic corticosteroid therapy (>10 mg prednisone equivalent per day) or other immunosuppressive treatment within 14 days before administration or during treatment. Inhaled or topical steroids and adrenal corticosteroid replacement therapy at ≤10 mg/day prednisone equivalent are allowed in the absence of active autoimmune disease.
History of any active immune-related or autoimmune disease, or a known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
Trial design
Treatments tested in this trial
- benmelstobart-Anlotinib-Chemo
Treatment groups
26 Participants
are divided into 1 treatment groupSponsors and collaborators
Jiangsu Cancer Institute & Hospital
Lead sponsor
Jiangsu Provincial Stomatological Hospital
Collaborator
Source ClinicalTrials.gov