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Neoadjuvant Anti-PD-1 and TP Versus TPF on Pathological Response in OSCC

ConditionsOral Squamous Cell CarcinomaNeoadjvant TherapyAnti-PD-1Chemotherapy
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Jiao Tong University School of Medicine

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age: 18-75 years old

Gender: male and female

Eastern Cooperative Oncology Group (ECOG) performance status (PS): 0-2

Histopathological diagnosis of oral squamous cell carcinoma (including tongue, gums, cheek, floor of mouth, hard palate, and posterior molar region)

Disqualifiers

Unresolved grade 2 [(Common Terminology Criteria for Adverse Events (CTCAE 5.0)] or higher toxic reactions caused by previous anticancer treatments

Known allergic reaction to any ingredients or excipients of the therapy

Known history of malignancy, unless been cured and no recurrence for 5 years

Known history of radiation to head and neck

Trial design

Design model

Parallel

Treatments tested in this trial

  • Toripalimab (anti-programmed death-1 inhibitor)

    Drug

    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.

  • Albumin paclitaxel

    Drug

    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.

  • Cisplatin

    Drug

    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.

  • Docetaxel

    Drug

    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.

  • 5-Fluorouracil

    Drug

    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.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Neoadjuvant TTPExperimental treatment 3 interventions
Group B: Neoadjuvant TPFActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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

2-year overall survival rate

Overall survival was calculated from the date of randomization to death from any cause.

Time frame
24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Jiao Tong University School of Medicine

Lead sponsor

Source ClinicalTrials.gov
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