NCT04718415

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for phase_2

Timeline
9mo left

Started Jan 2021

Longer than P75 for phase_2

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress88%
Jan 2021Jan 2027

First Submitted

Initial submission to the registry

January 19, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 22, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

January 23, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
4.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 23, 2027

Expected
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

1.9 years

First QC Date

January 19, 2021

Last Update Submit

September 17, 2024

Conditions

Oral Squamous Cell CarcinomaOropharyngeal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (2)

  • Adverse events graded by CTCAE v5.0

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

    90 days after the first dose of study treatment

  • Pathologic Response

    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.

    6 weeks

Secondary Outcomes (4)

  • Disease-free survival （DFS）

    2 years

  • Overall survival（OS）

    5 years

  • Radiographic Response

    5 weeks

  • Rate of surgery delay

    8 weeks after the patient receives their last dose

Study Arms (1)

sintilimab + carboplatin + nab-paclitaxel

EXPERIMENTAL

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.

Drug: sintilimab, paclitaxel, carboplatinProcedure: Surgical resection

Interventions

sintilimab, paclitaxel, carboplatinDRUG

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 + carboplatin + nab-paclitaxel
Surgical resectionPROCEDURE

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

sintilimab + carboplatin + nab-paclitaxel

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have a histologically confirmed diagnosis of OSCC or OPSCC which is planned for treatment with curative intent including surgical resection：stage II-IVA.
  • Greater than or equal to 18 and less than 80 years of age at time of study entry.
  • ECOG performance status of 0 or 1.
  • Measurable disease as per RECIST 1.1.
  • Patients must have no prior exposure to immune-mediated therapy, including anti- cytotoxic T-lymphocyte protein 4 (CTLA-4), anti-programmed cell death 1, anti-programmed cell death 1 ligand 1 (PD-L1), or anti-programmed cell death ligand 2 antibodies, excluding therapeutic anticancer vaccines.
  • Screening labs must meet the following criteria and must be obtained within 14 days prior to registration:
  • Adequate hepatic and renal function as demonstrated by
  • Serum creatinine \< 1.5 X ULN or CrCl \> 40mL/min (if using the Cockcroft-Gault formula below):
  • Males: Creatinine CL (mL/min) = (Weight (kg) x (140 - Age))/(72 x serum creatinine (mg/dL)）
  • Females: Creatinine CL (mL/min) = (Weight (kg) x (140 - Age))/(72 x serum creatinine (mg/dL))x 0.85
  • AST/ALT ≤ 3 x ULN
  • Total Bilirubin ≤ 1.5 x ULN (except subjects with Gilbert Syndrome, who can have total bilirubin \< 3.0 mg/dL)
  • Adequate bone marrow function as demonstrated by:
  • Absolute Neutrophil Count \>1,500/µL
  • Platelets \> 100 X 103/µL
  • +7 more criteria

You may not qualify if:

  • Is currently participating in or has participated in a study of an investigational agent within 4 weeks of the first dose of treatment or has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
  • Has had another known invasive malignancy within the previous 5 years and/or has had surgery, chemotherapy, targeted small molecule therapy or radiation therapy within 5 years for a known malignancy prior to study day 0.
  • If subject received major surgery for any other reason, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
  • Subjects with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of day -5. Inhaled or topical steroids, and adrenal replacement steroid \> 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
  • Has an active autoimmune disease requiring systemic steroid treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids.
  • Active, known or suspected autoimmune disease. Note: Subjects are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger .
  • Has evidence of interstitial lung disease or active, non-infectious pneumonitis.
  • Has an active infection requiring systemic therapy.
  • Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathways.
  • A history of allergic reaction attributed to compounds of similar chemical or biologic composition to the treatment or other agents used in the study.
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
  • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
  • Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 23 weeks after the last dose of trial treatment.
  • Has a known history of Human Immunodeficiency Virus (HIV) infection (HIV 1/2 antibodies).
  • Has known active Hepatitis B or C.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sun Yat-sen Memorial Hospital

Guangzhou, Guangdong, 510000, China

Location

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Guanzhou, Guangdong, 510000, China

Location

Related Publications (1)

  • Liu N, Wu J, Deng E, Zhong J, Wei B, Cai T, Xie Z, Duan X, Fu S, Osei-Hwedieh DO, Huang K, Zhuang P, Sha O, Chen Y, Lv X, Zhu Y, Zhang L, Lin H, Li Q, Lu P, Miao J, Yamada T, Cai L, Du H, Baca SC, Huang Q, Ferrone S, Wang X, Xu F, Fan X, Fan S. Immunotherapy and senolytics in head and neck squamous cell carcinoma: phase 2 trial results. Nat Med. 2025 Sep;31(9):3047-3061. doi: 10.1038/s41591-025-03873-7. Epub 2025 Aug 25.

    PMID: 40855191DERIVED

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

sintilimabPaclitaxelCarboplatin

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsHead and Neck NeoplasmsNeoplasms by Site

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesCoordination Complexes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 19, 2021

First Posted

January 22, 2021

Study Start

January 23, 2021

Primary Completion

January 1, 2023

Study Completion (Estimated)

January 23, 2027

Last Updated

September 19, 2024

Record last verified: 2024-09

Locations

CN(2)