Head and Neck CancerPhase 2NCT06793761
A Phase II Study to Evaluate the Efficacy and Safety of Salvage Preoperative PD-1 Inhibitor Combined with Chemotherapy Neoadjuvant Therapy in Recurrent and Metastatic LPSCC/HPSCC
A Phase 2 study testing Pembrolizumab, Cisplatin and Nab-paclitaxel in people with Head and Neck Cancer, run by Beijing Tongren Hospital.
Trial summary
A prospective, multicenter, randomized controlled phase II study; Patients who met the inclusion criteria were divided into groups according to whether they had received radical radiotherapy or postoperative radiotherapy in the past. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Pembrolizumab, Cisplatin and Nab-paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2025to 31 Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with histologically and/or cytologically diagnosed squamous cell carcinoma of the larynx and hypopharynx
- Patients with recurrence of primary lesions or second primary lesions after definitive treatment
- At least 6 months from the end of the last platinum-containing treatment
- Cisplatin-tolerant
- Age ≥ 18 years
- ECOG 0-1
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- Measurable disease as defined by RECIST v1.1
- Normal organ function
- Female and male participants of reproductive potential must agree to use appropriate contraception throughout the study and for 180 days after the last study treatment
- Male participants must not donate sperm throughout the study and for 180 days after the last study treatment
Who cannot join
- T stage after relapse (rT) is T4b
- Presence of distant metastasis
- Received live vaccines within 30 days before enrollment
- Diagnosed with immunodeficiency or received systemic steroids or any other form of immunosuppressive therapy within 7 days before enrollment
- Have radiologically detectable (even if asymptomatic and/or previously treated) central nervous system metastases and/or carcinomatous meningitis;
- Have undergone surgery before starting the study or have not recovered adequately from toxicity or complications caused by the intervention;
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- Have had allogeneic tissue/solid organ transplantation;
- Have severe hypersensitivity reactions (≥ grade 3) to PD-1 inhibitors and chemotherapy or any of its adjuvants, radiotherapy;
- Have active autoimmune disease and require systemic treatment in the past 2 years;
- Have a history of (non-infectious) pneumonia requiring steroid treatment;
- Have a history of human immunodeficiency virus (HIV) infection;
- Any medical history, treatment, or laboratory abnormality that could confound the study results, interfere with the participant's participation throughout the study, or be detrimental to the participant's best interests;
- A known history of psychiatric or substance abuse disorder
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective, Multicenter, Randomized Controlled Phase II Study to Evaluate the Efficacy and Safety of Salvage Preoperative PD-1 Inhibitor Combined with Chemotherapy Neoadjuvant Therapy in Recurrent and Metastatic Laryngeal and Hypopharyngeal Squamous Cell Carcinoma
A prospective, multicenter, randomized controlled phase II study; Patients who met the inclusion criteria were divided into groups according to whether they had received radical radiotherapy or postoperative radiotherapy in the past. Group A was the group that had not received radiotherapy in the past, and Group B was the group that had received radiotherapy. Group A was randomly given 3 cycles of pembrolizumab + chemotherapy (see P22 for detailed chemotherapy regimen) in the experimental group at a 1:1 ratio, followed by surgery. After surgery, the patients were stratified according to whether there were high-risk factors. The high-risk group received concurrent chemoradiotherapy + pembrolizumab maintenance therapy (up to 15 cycles), and the low-risk group received radiotherapy + pembrolizumab maintenance therapy (up to 15 cycles). The control group underwent direct surgery and received concurrent chemoradiotherapy or radiotherapy after surgery. The total dose of radiotherapy was (high-risk group: 60-66Gy, 2Gy/time; low-risk group: 44-50 Gy, 2Gy/time) adjuvant therapy, and the radiotherapy time was within 2 months after surgery. Group B was randomly given 3 cycles of pembrolizumab + chemotherapy in the experimental group at a ratio of 1:1, followed by surgery and maintenance therapy with pembrolizumab after surgery (up to 15 cycles). The control group was given surgery directly, and observation/re-radiotherapy or chemoradiotherapy was chosen by the doctor after surgery. The total dose of radiotherapy was (56-60Gy, 2Gy/time), and the radiotherapy time was within 2 months after surgery. The enrolled patients must be closely monitored for adverse reactions to chemotherapy, and the time, grade, treatment measures, and outcomes must be recorded. All patients received an examination after the end of neoadjuvant therapy, an examination after surgery, and an examination at the 9th week after the first radiotherapy, and then reviewed every 3 months for 1 year; after 1 year, they were reviewed once every 6 months for 3 years; the recurrence and survival data of the patients were recorded.
- Conditions
- Head and Neck Cancer
- Being tested
- Pembrolizumab, Cisplatin, Nab-paclitaxel
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PembrolizumabDrug
Pembrolizumab 200mg, IV, 3 cycles
CisplatinDrug
cisplatin 75mg/m2, IV, 3 cycles
Nab-paclitaxelDrug
Nab-paclitaxel 260mg, IV, 3 cycles
| Study group | Role | What they receive |
|---|---|---|
| Arm 1-Pembrolizumab group (no previous radiotherapy) | Experimental | Patients who had not received RT previously received 3 cycles of pembrolizumab + cisplatin + nab-paclitaxel, followed by SOC treatment Receives: Drug: Pembrolizumab; Drug: Cisplatin; Drug: Nab-paclitaxel |
| Arm 2 - Control group (no previous radiotherapy) | No intervention | Patients who had not received RT before received SOC treatment only |
| Arm 3 - Pembrolizumab group (previously received radiotherapy) | Experimental | Patients who had received RT before received 3 cycles of pembrolizumab + cisplatin + nab-paclitaxel, followed by SOC treatment Receives: Drug: Pembrolizumab; Drug: Cisplatin; Drug: Nab-paclitaxel |
| Arm 4 - Control group (previously received radiotherapy) | No intervention | Patients who had received RT before received SOC treatment only |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year progression-free survival rate (2y-PFS rate)
To evaluate the 2y-PFS rate of neoadjuvant PD-1 inhibitors combined with chemotherapy in Arm 1 and Arm 3; PFS was defined as the time from patient enrollment to the occurrence of the following events (local progression/recurrence or distant metastasis (including neoadjuvant stage) assessed by imaging or biopsy, death from any cause)
Measured: 2 year
Secondary outcomes (4)
Pathological complete response rate (pCR rate)
To evaluate the pCR rate of neoadjuvant PD-1 inhibitors combined with chemotherapy in Arm 1 and Arm 3; pCR was defined as the absence of residual invasive squamous cell carcinoma cells in the resected primary tumor specimen and lymph nodes
Measured: 3 months
Objective response rate (ORR)
To evaluate the ORR of neoadjuvant therapy with PD-1 inhibitors plus chemotherapy in Arm 1 and Arm 3; ORR is defined as The proportion of patients whose tumor volume shrinks to a pre-specified value and can be maintained for a certain period of time. It includes the proportion of patients with complete remission (CR) and partial remission (PR) to the total number of evaluable cases.
Measured: 6 months
3-year overall survival rate (3y-OS rate)
To evaluate the 3y-OS rate of neoadjuvant PD-1 inhibitors plus chemotherapy in Arm 1 and Arm 3 in the overall population; OS was defined as the time from randomization until death from any cause.
Measured: 3 years
Incidence of Treatment-Emergent Adverse Events (TRAEs) of pembrolizumab combined with chemotherapy in neoadjuvant therapy
TRAEs include 5 levels, base on Common Terminology Criteria for Adverse Events (CTCAE) is widely accepted as the standard classification and severity grading scale for adverse events in cancer therapy, clinical trials and other oncology settings.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start1 Feb 2025 (estimated)
- Primary completion20 Dec 2026 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tongren Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06793761
- Sponsor's protocol ID
- TRENT-002
- Status last verified
- Jan 2025
- First submitted
- 20 Jan 2025
- Last updated
- 27 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized Controlled Phase II Study to Evaluate the Efficacy and Safety of Salvage Preoperative PD-1 Inhibitor Combined with Chemotherapy Neoadjuvant Therapy in Recurrent and Metastatic Laryngeal and Hypopharyngeal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT06793761
- Acronym / sponsor ID
- TRENT-002
- Conditions
- Head and Neck Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Beijing Tongren HospitalUniversity, hospital or other
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- 20 Dec 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 27 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective, multicenter, randomized controlled phase II study; Patients who met the inclusion criteria were divided into groups according to whether they had received radical radiotherapy or postoperative radiotherapy in the past. Group A was the group that had not received radiotherapy in the past, and Group B was the group that had received radiotherapy. Group A was randomly given 3 cycles of pembrolizumab + chemotherapy (see P22 for detailed chemotherapy regimen) in the experimental group at a 1:1 ratio, followed by surgery. After surgery, the patients were stratified according to whether there were high-risk factors. The high-risk group received concurrent chemoradiotherapy + pembrolizumab maintenance therapy (up to 15 cycles), and the low-risk group received radiotherapy + pembrolizumab maintenance therapy (up to 15 cycles). The control group underwent direct surgery and received concurrent chemoradiotherapy or radiotherapy after surgery. The total dose of radiotherapy was (high-risk group: 60-66Gy, 2Gy/time; low-risk group: 44-50 Gy, 2Gy/time) adjuvant therapy, and the radiotherapy time was within 2 months after surgery. Group B was randomly given 3 cycles of pembrolizumab + chemotherapy in the experimental group at a ratio of 1:1, followed by surgery and maintenance therapy with pembrolizumab after surgery (up to 15 cycles). The control group was given surgery directly, and observation/re-radiotherapy or chemoradiotherapy was chosen by the doctor after surgery. The total dose of radiotherapy was (56-60Gy, 2Gy/time), and the radiotherapy time was within 2 months after surgery. The enrolled patients must be closely monitored for adverse reactions to chemotherapy, and the time, grade, treatment measures, and outcomes must be recorded. All patients received an examination after the end of neoadjuvant therapy, an examination after surgery, and an examination at the 9th week after the first radiotherapy, and then reviewed every 3 months for 1 year; after 1 year, they were reviewed once every 6 months for 3 years; the recurrence and survival data of the patients were recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1-Pembrolizumab group (no previous radiotherapy) | Experimental | Drug: Pembrolizumab, Drug: Cisplatin, Drug: Nab-paclitaxelPatients who had not received RT previously received 3 cycles of pembrolizumab + cisplatin + nab-paclitaxel, followed by SOC treatment |
| Arm 2 - Control group (no previous radiotherapy) | No intervention | –Patients who had not received RT before received SOC treatment only |
| Arm 3 - Pembrolizumab group (previously received radiotherapy) | Experimental | Drug: Pembrolizumab, Drug: Cisplatin, Drug: Nab-paclitaxelPatients who had received RT before received 3 cycles of pembrolizumab + cisplatin + nab-paclitaxel, followed by SOC treatment |
| Arm 4 - Control group (previously received radiotherapy) | No intervention | –Patients who had received RT before received SOC treatment only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients with histologically and/or cytologically diagnosed squamous cell carcinoma of the larynx and hypopharynx
- Patients with recurrence of primary lesions or second primary lesions after definitive treatment
- At least 6 months from the end of the last platinum-containing treatment
- Cisplatin-tolerant
- Age ≥ 18 years
Key exclusion criteria (13 listed)
- T stage after relapse (rT) is T4b
- Presence of distant metastasis
- Received live vaccines within 30 days before enrollment
- Diagnosed with immunodeficiency or received systemic steroids or any other form of immunosuppressive therapy within 7 days before enrollment
- Have radiologically detectable (even if asymptomatic and/or previously treated) central nervous system metastases and/or carcinomatous meningitis;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PembrolizumabPembrolizumab 200mg, IV, 3 cycles | Drug | Arm 1-Pembrolizumab group (no previous radiotherapy), Arm 3 - Pembrolizumab group (previously received radiotherapy) |
| Cisplatincisplatin 75mg/m2, IV, 3 cycles | Drug | Arm 1-Pembrolizumab group (no previous radiotherapy), Arm 3 - Pembrolizumab group (previously received radiotherapy) |
| Nab-paclitaxelNab-paclitaxel 260mg, IV, 3 cycles | Drug | Arm 1-Pembrolizumab group (no previous radiotherapy), Arm 3 - Pembrolizumab group (previously received radiotherapy) |
Primary outcome
2-year progression-free survival rate (2y-PFS rate)
Time frame: 2 year
To evaluate the 2y-PFS rate of neoadjuvant PD-1 inhibitors combined with chemotherapy in Arm 1 and Arm 3; PFS was defined as the time from patient enrollment to the occurrence of the following events (local progression/recurrence or distant metastasis (including neoadjuvant stage) assessed by imaging or biopsy, death from any cause)
4 secondary outcomes
Pathological complete response rate (pCR rate)
Time frame: 3 months
Objective response rate (ORR)
Time frame: 6 months
3-year overall survival rate (3y-OS rate)
Time frame: 3 years
Incidence of Treatment-Emergent Adverse Events (TRAEs) of pembrolizumab combined with chemotherapy in neoadjuvant therapy
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pembrolizumab, Cisplatin and Nab-paclitaxel in people with Head and Neck Cancer, run by Beijing Tongren Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaohong Chen (08658269106, trchxh@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year progression-free survival rate (2y-PFS rate) (time frame: 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2025.