Intra-arterial Chemotherapy Combined with Radiotherapy and Immunotherapy for HNSCC
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeijing Tongren Hospital
About this trial
This study pioneers a novel approach by integrating a new auxiliary chemo-immunotherapy regimen, which is then followed by an evaluation of the potential for surgical resection. For those patients who remain non-resectable, a tailored treatment plan is proposed, consisting of arterial infusion chemotherapy in conjunction with radiotherapy, succeeded by a series of immune checkpoint inhibitors. The efficacy and safety of this integrated therapeutic strategy are meticulously assessed, with the goal of enhancing survival outcomes for patients with T4bNanyM0 HNSCC.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with T4bNanyM0 Head and neck squamous cell carcinoma (hypopharyngeal cancer, laryngeal cancer, oropharyngeal cancer or oral cavity) with a confirmed diagnosis by histology and/or cytology;
Expected survival ≥3 months, with adequate organ function;
Investigators believe they can safely receive treatment with PD-1 combined with platinum and albumin-bound paclitaxel;
Age ≥18 years;
Disqualifiers
Patients with a history of prior immunotherapy, radiotherapy, and treatment with EGFR monoclonal antibodies;
Patients with a history of other (including unknown primary) malignant tumors within the past 5 years;
Patients who are intolerant to radiotherapy post-surgery;
Patients known to be allergic to the study medication or its active ingredients, excipients;
Trial design
Design model
Single group
Treatments tested in this trial
Tislelizumab-jsgr
Drug200mg, Q3W
Cisplatin
Drug60-75 mg/㎡, Q3W
Albumin-Bound Paclitaxel
Drug260 mg/㎡, Q3W
Radiotherapy
RadiationRadical Radiotherapy or adjuvant Radiotherapy per guidelines.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: RT + IAC + Anti-PD-1 antibodyExperimental treatment 4 interventions
Trial outcomes
Primary outcomes
1
1 year Event-free Survival rate (1y-EFS rate)
EFS is the time from the starting date of neoadjuvant therapy to the date of first record of any of the following events: radiographic disease progression; local or distant progression or recurrence as assessed with imaging or biopsy as indicated; or death due to any cause. Radiographic disease progression during neoadjuvant phase that precludes surgery will be considered an event; a secondary malignancy will not be considered an event.
Time frame
1 yearSecondary outcomes
1
Objective Response Rate (ORR)
ORR was defined as the percentage of participants in the analysis population who have a Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1.
Time frame
Up to 30 days post-neoadjuvant2
Pathological Complete Response (pCR)
Pathological complete response (pCR) is measured as the percentage of participants with a pathological complete response as assessed by the central pathologist at the time of definitive surgery. pCR is defined as having no residual invasive squamous cell carcinoma within the resected primary tumor specimen and all sampled regional lymph nodes.
Time frame
Up to 30 days post-surgery3
Major Pathological Response (MPR)
The percentage of participants with a major pathological response (mPR) as assessed by the Central Pathologist at the time of definitive surgery. mPR is defined as ≤10% invasive squamous cell carcinoma within the resected primary tumor specimen and all the sampled regional lymph nodes.
Time frame
Up to 30 days post-surgery4
Overall Survival (OS)
OS was defined as the time from starting date of neoadjuvant therapy to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up.
Time frame
Up to 5 yearsSponsors and contacts
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Source ClinicalTrials.gov