Neoadjuvant Toripalimab Plus Nimotuzumab in Oral Squamous Cell Carcinoma Prior to Radical Therapy

NCT05803915 | Not Yet Recruiting Phase 2

• 1 other identifier: JS001-ISS-CO407
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to investigate the efficacy and safety of neoadjuvant Toripalimab combined with Nimotuzumab in primary limited stage oral squamous cell carcinoma prior to radical therapy.

Conditions

Oral Squamous Cell Carcinoma

Keywords

Oral Squamous Cell Carcinoma; Toripalimab; Neoadjuvant; PD-1 inhibitor

Outcome Measures

Primary Outcomes (1)

• Major Pathologic response (MPR) rate

  MPR rate is defined as the proportion of participants who have achieved major pathological response（on routine hematoxylin and eosin staining, tumors with no more than 10% viable tumor cells) in all participants who have completed the neoadjuvant therapy and underwent surgery.

  up to 18 months

Secondary Outcomes (7)

• Objective response rate (ORR)

  up to 18 months

• 2-year disease-free survival rate (DFS)

  up to 42 months

• 2-year progression-free survival rate (PFS)

  up to 42 months

• 2-year overall survival rate (OS)

  up to 42 months

• Change in PD-L1 expression

  up to 42 months

Other Outcomes (2)

• Change in Lymphocyte phenotype

  up to 42 months

• Change in Immunostimulatory cytokines

  up to 42 months

Study Arms (1)

Neoadjuvant Toripalimab plus Nimotuzumab

EXPERIMENTAL

The participants will receive 2 doses of neoadjuvant Toripalimab plus Nimotuzumab, then the participants will take a radical surgery or radiotherapy according to the efficacy assessed by investigator per RECIST1.1

Drug: Toripalimab

Interventions

Toripalimab DRUG

The participants will receive Toripalimab 240mg intravenous infusion every 3 week, and Nimotuzumab 150mg/㎡ every 2 week for 2 cycles

Also known as: JS001

Neoadjuvant Toripalimab plus Nimotuzumab

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged ≥18 years old；male or female.
• Oral squamous cell carcinoma confirmed by cytology or histology. Evaluation by the investigators to confirmed primary limited-stage (clinical stage T1N+M0, T2-4 anyNM0, AJCC 8th) without prior treatment.
• Patients who are suitable and agree radical therapy.
• At least 1 evaluable lesion according to RECIST v1.1.
• ECOG PS ≤ 1
• Adequate organ function, defined as achieving the following laboratory test results ≤ 14 days before treatment
• Patients must meet the following laboratory test results: i. ANC ≥ 1.5 x 10\^9 / L ii. Platelets ≥100 x 10\^9 / L iii. Hb ≥90 g / L Note: Patients must not receive blood transfusion or growth factor within 14 days before blood sample collection due to neutrophil count, platelet, or hemoglobin below study requirements.
• Renal function requirements within 4 weeks before treatment: Endogenous creatinine clearance ≥ 60 mL / min or more (based on 24-hour urine creatinine calculation or Cockcroft-Gault formula method).
• Serum total bilirubin ≤ 1.5×ULN (Gilbert syndrome patients can be enrolled if the total bilirubin is \<3 × ULN).
• AST and ALT ≤ 3 × ULN. If the patient has liver metastases, AST and ALT ≤ 5×ULN
• Patients with hepatitis B virus (HBV) infection and inactive / asymptomatic HBV carriers; or patients with chronic or active HBV, if HBV DNA \<500 IU / mL (or 2500 copies/ mL) will be allowed to enroll. Hepatitis C antibody-positive patients will be allowed to enroll if HCV-RNA is negative during screening.
• NOTE: Patients with detect hepatitis B surface antigen (HBsAg) or HBV DNA, and patients receiving antiviral therapy during screening should be treated for\> 2 weeks before enrollment, and Continue treatment for 6 months after study drug therapy
• Women of childbearing age (WOCBP) must be willing to take effective contraception during the study period and ≥60 days after the last study treatment (including chemotherapy) administration, and the urine or serum pregnancy test result is negative within ≤7 days before treatment.
• a. Women of childbearing age are defined as any woman who has had menarche and has not undergone sterilization (hysterectomy or bilateral ovariectomy) and has not yet reached menopause. Menopause is defined as amenorrhea for 12 months in women\> 45 without other biological or physiological causes. In addition, to confirm menopause, women under 55 must have serum follicle stimulating hormone (FSH) levels\> 40 mIU / mL.
• Unsterilized male must be willing to take effective contraception during the study and ≥ 60 days after the last study treatment (including chemotherapy) was administered.

You may not qualify if:

• Not suitable for toripalimab or nimotuzumab treatment.
• Have previously received any treatment for oral squamous cell carcinoma.
• Patients with evidence of fistula (esophagus / bronchus or esophagus / aorta)
• Presence of uncontrollable pleural effusion, pericardial effusion, or ascites that require repeated drainage or medical intervention (with clinically significant recurrence requiring additional intervention within 2 weeks after the intervention).
• Evidence of complete esophageal obstruction that is not suitable for treatment
• Have been treated with antitumor agents targeted to PD-1, PD-L1 or PD-L2.
• Have active meningeal disease or uncontrolled brain metastases.
• Patients with active autoimmune disease or history of autoimmune diseases may relapse.
• Note: Patients with the following diseases can be entered for further screening:
• Controllable type 1 diabetes
• Hypothyroidism (only if it could be controlled by hormone replacement therapy)
• Controlled celiac disease
• Skin diseases that do not require systemic treatment (eg vitiligo, psoriasis, hair loss)
• Any other disease that is not expected to recur without external triggers
• Any active malignancy within ≤ 2 years before treatment, expect specific cancers which being studied in this study and locally recurrent cancers that have been cured (such as resected basal cell or squamous cell skin cancer, superficial bladder cancer, cervical cancer and breast cancer in situ).

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, 100730, China

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

toripalimab

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Central Study Contacts

Ning Jia

CONTACT

13161312858; doctorjn@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2023
• First Posted: April 7, 2023
• Study Start: May 1, 2023
• Primary Completion: September 30, 2024
• Study Completion: March 10, 2026
• Last Updated: April 7, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)