Clinical trial · Interventional
Advanced First-line Treatment of Short-term Postoperative Progression of Head and Neck Squamous Cell Carcinoma
A Single-arm,Single Center,Prospective,Phase II Clinical Study of Camrelizumab Combined With Concurrent Chemoradiotherapy for Short-term Postoperative Progression of Head and Neck Squamous Cell Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Squamous Cell Carcinoma | Head and Neck Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Camrelizumab | Drug | Camrelizumab | ALIAS |
| Carboplatin | Drug | Carboplatin | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Lobaplatin | Drug | — | UNRESOLVED |
| Nedaplatin | Drug | Nedaplatin | ALIAS |
| Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Camrelizumab+(Cisplatin or Carboplatin or Lobaplatin or Nedaplatin)+radiotherapy
- description
- patients with short-term postoperative progression receive camrelizumab and platin-based chemotherapy concurrent with radiotherapy.
- interventionNames
- Drug: Camrelizumab
- Drug: Cisplatin
- Drug: Carboplatin
- Drug: Lobaplatin
- Drug: Nedaplatin
- Radiation: Radiotherapy
Primary outcomes (1)
- measure
- 1 year Progression-free survival (1y-PFS)
- timeFrame
- up to 1 years
- description
- Proportion of patients with disease-free survival at 3 years after randomization
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * 1.Sign written informed consent before implementing any test related processes; * 2.Male or female subjects aged from 18 to 70 years old; * 3.For head and neck squamous cell carcinoma after standard radical resection and neck lymph node dissection, the number of lymph node dissections is unlimited; * 4.No neoadjuvant therapy was received before operation and no adjuvant therapy was received after operation; * 5.Local or regional recurrence has been confirmed by at least 2 radiographs and a pathological diagnosis is not required; * 6.The time of recurrence was less than 6 months from operation; * 7.Whole body imaging to rule out distant metastases; * 8.Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1 at trial entry; * 9.Adequate haematological, hepatic and renal functions defined by the protocol; * 10.Estimated life expectancy of more than 1year; * 11.No history of pD-1 or PD-L1 inhibitor treatment; * 12.No underlying diseases requiring immunosuppressive therapy; * 13.PD-L1 status is not required, but PD-L1 IHC detection is recommended; * 14.Women of reproductive age must undergo a negative urinary pregnancy test within 7 days before starting treatment Exclusion Criteria: * 1.The primary site is squamous cell carcinoma of the nasopharynx or skin; * 2.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); * 3.Currently participating in intervention clinical research treatment, or receiving other research drugs or using research instruments within 4 weeks before the first administration; * 4.Previously received anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs that stimulate or synergistically inhibit T cell receptors; * 5.Prior organ transplantation, including allogeneic stem-cell transplantation(except corneal transplantation); * 6.Known history of allergy to the drug components of this regimen; * 7.There are multiple factors (e.g. severe renal insufficiency, bone marrow suppression) that influence the chemotherapeutic agent selected by the investigator; * 8.Before starting treatment, it has not fully recovered from the toxicity and / or complications caused by any intervention; * 9\. 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; * 10.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; * 11.History of uncontrolled intercurrent illness including hypertension, active infection, diabetes , hereditary bleeding , coagulopathy with a risk of bleedingor, cardiac diseases or symptoms; * 12.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; * 13.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; * 14.Used immunosuppressive drugs within 14 days before the first dose of study drug, excluding nasal and inhaled corticosteroids or physiological doses of systemic corticosteroids;
References
Publications (0)
Data not yet available