Advanced First-line Treatment of Short-term Postoperative Progression of Head and Neck Squamous Cell Carcinoma

NCT06170697 | Unknown Phase 2

• 1 other identifier: 22-OBU-BJ-HNC-II-008
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

Every year, about 6% of patients with malignant tumors are diagnosed as head and neck cancer. There are about 650000 new cases and 350000 deaths. A considerable number of patients have simple local recurrence in the short term after operation suggesting that the biological behavior of this kind of tumor is relatively more invasive and the overall prognosis is poor. This project intends to study the efficacy and safety of camrelizumab combined with concurrent chemoradiotherapy for short-term postoperative progression of head and neck squamous cell carcinoma.

Conditions

Head and Neck Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• 1 year Progression-free survival (1y-PFS)

  Proportion of patients with disease-free survival at 3 years after randomization

  up to 1 years

Secondary Outcomes (5)

• Objective Response Rate（ORR）

  From the start of randomization to a minimum of 24 months

• Disease Control Rate (DCR)

  From the start of randomization to a minimum of 24 months

• Duration of Response (DoR)

  From the start of randomization to a minimum of 48 months

• Overall survival (OS)

  From the start of randomization to a minimum of 48 months

• Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0

  From the the first dose of study drug administration up to 28 days after the last dose of study drug administration, assessed up to 2 years

Study Arms (1)

Camrelizumab+（Cisplatin or Carboplatin or Lobaplatin or Nedaplatin）+radiotherapy

EXPERIMENTAL

patients with short-term postoperative progression receive camrelizumab and platin-based chemotherapy concurrent with radiotherapy.

Drug: Camrelizumab; Drug: Cisplatin; Drug: Carboplatin; Drug: Lobaplatin; Drug: Nedaplatin; Radiation: Radiotherapy

Interventions

Camrelizumab DRUG

200mg, iv, d1, q3w

Also known as: immunotherapy

Camrelizumab+（Cisplatin or Carboplatin or Lobaplatin or Nedaplatin）+radiotherapy

Cisplatin DRUG

80-100mg/m2, iv, q3w, 2-3 cycles in total

Also known as: chemotherapy

Camrelizumab+（Cisplatin or Carboplatin or Lobaplatin or Nedaplatin）+radiotherapy

Carboplatin DRUG

AUC 2, iv, q1w, 5-7 cycles in total

Also known as: chemotherapy

Camrelizumab+（Cisplatin or Carboplatin or Lobaplatin or Nedaplatin）+radiotherapy

Lobaplatin DRUG

30mg/m2, iv, q3w, 2-3 cycles in total

Also known as: chemotherapy

Camrelizumab+（Cisplatin or Carboplatin or Lobaplatin or Nedaplatin）+radiotherapy

Nedaplatin DRUG

25-30 mg/m2, iv, q1w, 5-7 cycles in total

Also known as: chemotherapy

Camrelizumab+（Cisplatin or Carboplatin or Lobaplatin or Nedaplatin）+radiotherapy

Radiotherapy RADIATION

PGTVp/PGTVnd 66-70Gy/2-2.2Gy/30-35F；PTV1 60Gy/1.8-2.0Gy/30-33F；PTV2 50Gy/1.8-20Gy/25-28F；Start 1-2 weeks after the start of immunotherapy, 1 time before the start of simultaneous chemotherapy, up to 3 times during the concurrent chemoradiotherapy

Also known as: radiation therapy

Camrelizumab+（Cisplatin or Carboplatin or Lobaplatin or Nedaplatin）+radiotherapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sign written informed consent before implementing any test related processes;
• Male or female subjects aged from 18 to 70 years old;
• For head and neck squamous cell carcinoma after standard radical resection and neck lymph node dissection, the number of lymph node dissections is unlimited;
• No neoadjuvant therapy was received before operation and no adjuvant therapy was received after operation;
• Local or regional recurrence has been confirmed by at least 2 radiographs and a pathological diagnosis is not required;
• The time of recurrence was less than 6 months from operation;
• Whole body imaging to rule out distant metastases;
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1 at trial entry;
• Adequate haematological, hepatic and renal functions defined by the protocol;
• Estimated life expectancy of more than 1year;
• No history of pD-1 or PD-L1 inhibitor treatment;
• No underlying diseases requiring immunosuppressive therapy;
• PD-L1 status is not required, but PD-L1 IHC detection is recommended;
• Women of reproductive age must undergo a negative urinary pregnancy test within 7 days before starting treatment

You may not qualify if:

• The primary site is squamous cell carcinoma of the nasopharynx or skin;
• Previous malignant disease within the last 5 years with the exception of basal or squamous cell carcinoma of the skin or carcinoma in situ (bladder, cervical, colorectal, breast)；
• Currently participating in intervention clinical research treatment, or receiving other research drugs or using research instruments within 4 weeks before the first administration;
• Previously received anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs that stimulate or synergistically inhibit T cell receptors;
• Prior organ transplantation, including allogeneic stem-cell transplantation(except corneal transplantation)；
• Known history of allergy to the drug components of this regimen;
• There are multiple factors (e.g. severe renal insufficiency, bone marrow suppression) that influence the chemotherapeutic agent selected by the investigator;
• Before starting treatment, it has not fully recovered from the toxicity and / or complications caused by any intervention;
• \. Patients with congenital or acquired immune deficiency, such as human immunodeficiency virus (HIV) infection, Active tuberculosis, active hepatitis B (HBV DNA \<1000 copy/ml,200 IU/ml), hepatitis C (HCV antibody positive and HCV-RNA higher than the detection limit of the analytical method), or co infection of hepatitis B and hepatitis C;
• Accination with live or live/attenuated viruses within 4 weeks of the first dose of camrelizumab and while on trial is prohibited except for administration of inactivated vaccines;
• History of uncontrolled intercurrent illness including hypertension, active infection, diabetes , hereditary bleeding , coagulopathy with a risk of bleedingor, cardiac diseases or symptoms;
• Patients with past and current interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-associated pneumonia, and severe impaired lung function may interfere with the detection and management of suspected drug-associated pulmonary toxicity;
• Any active autoimmune disease or history of autoimmune disease (such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (can be included after hormone replacement therapy)); The subjects with childhood asthma who had been completely relieved and did not need any intervention or vitiligo in adulthood could be included, but the subjects who needed bronchodilator for medical intervention could not be included;
• Used immunosuppressive drugs within 14 days before the first dose of study drug, excluding nasal and inhaled corticosteroids or physiological doses of systemic corticosteroids;

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, 100020, China

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

camrelizumab; Immunotherapy; Cisplatin; Drug Therapy; Carboplatin; lobaplatin; nedaplatin; Radiotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Immunomodulation; Biological Therapy; Therapeutics; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes; Organic Chemicals

Study Officials

• Jingbo Wang

  Chinese academy of medical science, cancer hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jingbo Wang

CONTACT

+8618500369703; wangjingbo201001@163.com

Gulidanna Shayan

CONTACT

18500369703; gldanna@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: December 6, 2023
• First Posted: December 14, 2023
• Study Start: March 1, 2023
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2025
• Last Updated: December 20, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)