Neoplasms

All Conditions

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Head and Neck Neoplasms

Oral Squamous Cell Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Albumin-Bound Paclitaxel

Carboplatin

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Tubulin Modulators

Antimitotic Agents

Treatment with sintilimab, nab-paclitaxel and carboplatin for up to 2 - 4 cycles:

Sintilimab (IV), dose= 200mg , day=1 , cycle length: 21 days. Carboplatin (IV), dose=300mg/m2, day= 1, cycle length: 21 days. Nab-paclitaxel (IV), dose=260mg/m2, day= 1, cycle length: 21 days.

Patients receive sintilimab IV on day 1, paclitaxel IV on day 1 and carboplatin IV on day 1 . Treatment repeats every 21 days for up to 2 - 4 courses in the absence of disease progression or unacceptable toxicity.

sintilimab, paclitaxel, carboplatin

Surgical therapy will be at the discretion of the treating surgeon per standard of care.

Surgical resection

Song Fan, Doctor degrees

Tingting Cai, Bachelor's Degrees

Song Fan, Doctor degree

Tingting Cai, Bachelor degree

Jinsong Li, Doctor degree

The purpose of this study is to look at the efficacy and safety of sintilimab in combination with carboplatin and nab-paclitaxel in patients with oral cavity or oropharyngeal squamous cell carcinoma who are about to undergo surgery. Monoclonal antibodies, such as sintilimab, may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as carboplatin and nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving sintilimab, carboplatin, and nab-paclitaxel may work better in treating patients with oral cavity and oropharyngeal squamous cell carcinoma.

Neoadjuvant Sintilimab in Combination With Carboplatin and Nab-paclitaxel in Resectable Oral Cavity or Oropharyngeal Squamous Cell Carcinoma

Phase II Trial of Sintilimab, an Anti-PD-1 Monoclonal Antibody, in Combination With Carboplatin and Nab-paclitaxel , as a Novel Neoadjuvant Pre-Surgical Therapy for Oral Cavity or Oropharyngeal Squamous Cell Carcinoma

Percentage of adverse events that are possibly, probably or definitely related to study treatment per Criteria for Adverse Events version 5 (CTCAE v5.0).

Pathologic response to neoadjuvant treatment in resected tumor and lymph nodes. The rate of major pathologic response, defined as \<10% residual viable tumor cells in the resection specimen will be compared to historic data with neoadjuvant chemotherapy.

DFS is defined as the time from treatment until the date of the first relapse (local/regional recurrence or distant metastasis) or death (from any cause) whichever comes firsts and regardless of whether the patient withdraws from treatment or receives another anti-cancer therapy prior to disease relapse.

Overall survival will be defined as the time from day 1 of study treatment until death from any cause.

Radiographic response to treatment as defined by RECIST 1.1.

Rate of patients with an Unplanned Delay to Surgery defined as any change to scheduled surgery date considered to be at least possibly related to neoadjuvant treatment.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Neoadjuvant Sintilimab in Combination With Carboplatin and Nab-paclitaxel in Resectable Oral Cavity or Oropharyngeal Squamous Cell Carcinoma	NCT04718415	Oral Squamous C... Oropharyngeal S...	sintilimab, pac... Surgical resect...	18 Years - 80 Years	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Neoadjuvant Sintilimab in Combination With Carboplatin and Nab-paclitaxel in Resectable Oral Cavity or Oropharyngeal Squamous Cell Carcinoma	NCT04718415	Oral Squamous C... Oropharyngeal S...	sintilimab, pac... Surgical resect...	18 Years - 80 Years	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Spots Global Cancer Trial Database for sintilimab, paclitaxel, carboplatin