A Phase 2/3 interventional study of Toripalimab (anti-programmed death-1 inhibitor) and Albumin paclitaxel in Oral Squamous Cell Carcinoma, Neoadjvant Therapy and Anti-PD-1, sponsored by Shanghai Jiao Tong University School of Medicine. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-11-22.
Sponsored by Shanghai Jiao Tong University School of Medicine · Phase 2/3, Interventional, and Treatment
To compare the pathological efficacy of neoadjuvant Toripalimab and Albumin paclitaxel /Cisplatin (TTP) with Docetaxel/ Cisplatin/ 5-flurouracil (TPF) for patients with locally advanced resectable oral squamous cell carcinoma (OSCC), and to determine the safety of neoadjuvant TTP. In order to explore a better protocol of neoadjuvant therapy to improve the efficacy in patients with locally advanced OSCC.
In the previous "Illuminate" trial, neoadjuvant anti-programmed death-1 (PD-1) of Toripalimab and Albumin paclitaxel /Cisplatin (TTP) therapy was used in 20 patients with locally advanced and resectable oral squamous cell carcinoma (OSCC), and the neoadjuvant therapy was well-tolerated. The major pathologic response (MPR) rate was 60% (12/20), including 30% (6/20) pathological complete response (pCR). Furthermore, the MPR might transfer to survival benefit in the patients received neoadjuvant therapy. Therefore, in this randomized trial, we aimed to compare the pathological response of neoadjuvant TTP therapy versus TPF chemotherapy in the patients with locally advanced OSCC (Illuminate-2 trial). A total of 80 patients will be enrolled in this trial, and the primary endpoint is MPR rate. The neoadjuvant TTP arm will receive two cycles of intravenous Albumin paclitaxel (260mg/ m\^2), Cisplatin (75mg/ m\^2) and Toripalimab (anti-PD1 inhibitor, 240 mg) on d1 and d22, followed by the standard treatment of surgery and postoperative adjuvant therapy. The neoadjuvant TPF arm will received two cycles of intravenous Docetaxel (75mg/m\^2), Cisplatin (75mg/m\^2) on d1 (d22), and 5-Fu(750mg/m\^2/day) for 5 days (d1-5 and d22-26), followed by the standard treatment of surgery and postoperative adjuvant therapy.
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Exclusion Criteria:
The participants will receive two cycles of intravenous Albumin paclitaxel (260mg/ m\^2), Cisplatin (75mg/ m\^2) and Toripalimab (anti-PD-1 inhibitor, 240 mg) on d1 and d22.
Drug: Toripalimab (anti-programmed death-1 inhibitor) · Drug: Albumin paclitaxel · Drug: Cisplatin
The participants will receive two cycles of intravenous Docetaxel (75 mg/m\^2) on d1 and d22, Cisplatin (75 mg/m\^2) on d1 and d22, and 5-Fluorouracil (750 mg/m\^2/day) for 5 days (d1-5 and d22-26), the interval is 16±1 days.
Drug: Cisplatin · Drug: Docetaxel · Drug: 5-Fluorouracil
The participants will receive two cycles of Toripalimab, with 21 days each. 240mg of Toripalimab will be used intravenously on the first day of each cycle.
The participants will receive two cycles of Albumin paclitaxel, with 21 days each. 260mg/m\^2 of Albumin paclitaxel will be used intravenously on the first day of each cycle.
The participants will receive two cycles of Cisplatin, with 21 days each. 75mg/m\^2 of Cisplatin will be used intravenously on the first day of each cycle.
The participants will receive two cycles of Docetaxel, with 21 days each. 75mg/m\^2 of Docetaxel will be used intravenously on the first day of each cycle.
The participants will receive two cycles of 5-Fluorouracil, with 21 days each. 750mg/m\^2/d of 5-Fluorouracil will be used as a 120-hour continuous intravenous infusion on days 1 through 5.
Major pathologic response
The major pathologic response (MPR): the percentage of tumor cells before and after treatment was compared according to biopsy specimens before neoadjuvant therapy and pathological specimens after surgery; the percentage of residual viable tumor (RVT) cells was evaluated on resected tumor slides. MPR was defined as ≤ 10% RVT%.
Time frame: 3 months
2-year disease-free survival rate
Disease-free survival was calculated from the date of randomization to tumor recurrence or death from any cause.
Time frame: 24 months
2-year overall survival rate
Overall survival was calculated from the date of randomization to death from any cause.
Time frame: 24 months
Plan to share: Yes — The study protocol and the primary study report might be shared depending on the condition of trial completion.
Supporting information: Study protocol, Sap, Icf
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Shanghai Jiao Tong University School of Medicine