Hypopharyngeal CancerPhase 2NCT05860335
Efficacy and Safety of Toripalimab Combined With AP-induced Chemotherapy Followed in Non-metastatic IVB Hypopharyngeal Cancer
A Phase 2 study testing Cisplatin/Nedaplatin, albumin paclitaxel in people with Hypopharyngeal Cancer, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
The goal of this type of study: single center exploratory clinical trial is to evaluate the efficacy and safety of Toripalimab combined with AP-induced chemotherapy followed by concurrent chemoradiotherapy and Toripalimab-maintenance therapy sequentially in patients with non-metastatic IVB hypopharyngeal cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hypopharyngeal Cancer
- What is being tested?
- Cisplatin/Nedaplatin, albumin paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2021to 1 Jun 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 70 years old
- The clinical stage was Ivb stage (AJCC 8th edition),
- ECOG score was 0-1
- Have not received any anti-tumor therapy such as radiotherapy, chemotherapy, immunotherapy or biological therapy
- No contraindications of chemotherapy, immunotherapy and radiotherapy
- The functional level of major organs conforms to the following criteria: 1) the standard of blood routine examination should meet the following criteria: WBC ≥ 3.0x109, G-CSF and other hematopoietic stimulating factors. 2) biochemical tests should meet the following criteria: TBIL ≤ 2.0 × ULN,ALT, AST ≤ 2.5 × ULN,BUN and CRE ≤ 1.5 × ULN or endogenous creatinine clearance ≥ 60ml/min (Cockcroft-Gault formula); 3) good coagulation function: defined as international standardized ratio (INR) or prothrombin time (PT) ≤ 1.5 times ULN; if the subject is receiving anticoagulant therapy, as long as PT is within the range of anticoagulant use. 4) Myocardial zymogram is within the range of normal value;
- Women of childbearing age must have taken reliable contraceptive measures, or conducted pregnancy tests (serum or urine) within 7 days before admission, and the results were negative, and were willing to use effective methods of contraception during the trial period and within 2 months after the last administration of anti-PD-1 antibody. For male subjects whose partners are women of childbearing age, effective methods of contraception should be used during the trial and within 2 months after the last administration of anti-PD-1 antibody. 8. The subjects voluntarily joined the study, signed the informed consent form, had good compliance and cooperated with follow-up.
Who cannot join
- Previous or simultaneous suffering from other uncured malignant tumors, except cured basal cell carcinoma of the skin, carcinoma in situ of the cervix and superficial bladder cancer
- Patients with hypopharyngeal necrosis at the same time with the risk of bleeding.
- Suffer from any active autoimmune disease or have a history of autoimmune disease (e.g. interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (can be included when hormone replacement therapy is normal). Patients with vitiligo or asthma who have been completely relieved in childhood and can be included after adulthood without any intervention, and asthma patients who need bronchodilators for medical intervention can not be included.
- Suffering from uncontrolled cardiovascular disease: myocardial ischemia or myocardial infarction of grade Ⅱ or above, poorly controlled arrhythmias (including QTc interval ≥ 470ms); cardiac insufficiency of grade Ⅲ ~ IV according to NYHA criteria, or left ventricular ejection fraction (LVEF) < 50% indicated by color Doppler ultrasound; myocardial infarction occurred within 1 year.
- There is an active infection or an unexplained fever occurs during the screening period and before the first administration of the drug > 38.5 ℃ (according to the researchers, the fever caused by the tumor can be included in the group).
- Suffer from congenital or acquired immune deficiency (such as HIV infection), active hepatitis B (HBV-DNA ≥ 104copies / ml) or hepatitis C (hepatitis C antibody positive and HCR-RNA higher than the lower limit of detection by analytical method).
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- Have previously received other PD-1 antibody therapy or other immunotherapy for PD-1/PD-L1.
- Known to be allergic to paclitaxel, cisplatin, macromolecular protein preparations, or any anti-PD-1 antibody component.
- If the subject has undergone a major operation, the toxic reactions and / or complications caused by the surgical intervention must be fully recovered before starting the treatment.
- Within 4 weeks before the first use of research drugs (subjects who have entered the follow-up period are calculated on the basis of their last use of experimental drugs or devices) or are participating in other clinical studies.
- Live vaccine and COVID-19 vaccine are given within 4 weeks before the first use of the study; inactivated virus vaccine for seasonal influenza is allowed; live attenuated influenza vaccine for nasal use is not allowed.
- Pregnant or lactating women.
- The researchers determined that the subjects had other factors that might force them to stop the study, such as other serious illnesses (including mental illness) requiring combined treatment, seriously abnormal laboratory tests, family or social factors, which may affect the safety of the subjects or the collection of trial data.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety ofToripalimab Combined With AP-induced Chemotherapyfollowed by Concurrent Chemoradiotherapy and Toripalimab-maintenance Therapysequentially in Patients With Non-metastatic IVB Hypopharyngeal Cancer : Aopen-lablc, Single-arm ,Phase II Clinical Study
The goal of this type of study: single center exploratory clinical trial is to evaluate the efficacy and safety of Toripalimab combined with AP-induced chemotherapy followed by concurrent chemoradiotherapy and Toripalimab-maintenance therapy sequentially in patients with non-metastatic IVB hypopharyngeal cancer. The main question[s] it aims to answer are: • [main objectives: to evaluate the objective remission rate (ORR), progression-free survival (PFS) and safety of PD-1 inhibitor Toripalimab combined with induction chemotherapy (cisplatin / nedaplatin + albumin paclitaxel) in patients with locally advanced head and neck squamous cell carcinoma according to RECISTv1.1.] • [Secondary objectives: 1-year, 2-year, 3-year progression-free survival rate (PFS); 1-year, 2-year, 3-year overall survival rate (OS); overall survival time (OS); tumor regression time; quality of life was evaluated by ECOG physical status and EQ-5D-5L assessment. ] [Exploratory Objective: to explore the relationship between the biomarkers in tumor tissue and / or blood, including PD-L1 (CPS/TPS), HPV (P16), PD-1, TMB, EGFR, CD3, CD4, CD8, TP53, MSI-H and the efficacy of immunotherapy, and the relationship between MDM2/MDM4, EGFR, chromosome 11q13 interval (CCND1/FGF19/FGF3/FGF4) and immune hyperprogression] Participants will [be treated with Toripalimab injection (240mg/, once every 3 weeks) combined with cisplatin / nedaplatin (40mg) and albumin paclitaxel (230mg/m2, once every 3 weeks). The efficacy was evaluated within 1 week after induction therapy. In the phase of simultaneous radiotherapy, albumin paclitaxel (230mg/m2, once every 3 weeks, D1/D21/D43) was used. One month after the end of synchronous radiotherapy and chemotherapy, the efficacy was evaluated. After evaluation, all patients entered the next stage of immune maintenance therapy. During the maintenance phase, Toripalimabv injection (240mg/, once every 3 weeks) was given for 6 months or until the disease progressed, the toxicity was intolerable, the subjects asked to withdraw voluntarily, and the researchers judged that the subjects needed to withdraw from the study. The patients were treated with spiral tomographic radiotherapy (TOMO) or intensity modulated radiotherapy (IMRT).. These patients were given Nimotuzumab injection at the same time during simultaneous radiotherapy and chemotherapy.
- Conditions
- Hypopharyngeal Cancer
- Being tested
- Cisplatin/Nedaplatin, albumin paclitaxel
- Keywords
- non-metastatic IVB hypopharyngeal cancer, Toripalimab, Combine therapy
- Medical subject headings
- Hypopharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cisplatin/Nedaplatin, albumin paclitaxelDrug
During induction chemotherapy, triplelimab JS001 was administered before cisplatin/Nedaplatin and albumin paclitaxel. JS001 Intravenous infusion of cisplatin/Nedaplatin was administered 60 minutes after the end of infusion and beginning on day 1 of each cycle 40mg/m 2, D1, D2 albumin paclitaxel 230 mg/m 2; Chemotherapeutic drugs are administered in accordance with the drug label and local prodrome and other standard protocols for prophylactic use, every 3 Once a week (Q3W) for 2 cycles
| Study group | Role | What they receive |
|---|---|---|
| Toripalimab +AP-induced chemotherapy | Experimental | Study drug: toripalimab JS001 dosage：240mg Drug administration plan and mode：Intravenous infusion of 30min (not less than 20min and not more than 60min), followed by observation of 60min (only the first 2 cycles), once every 3 weeks (Q3W). Receives: Drug: Cisplatin/Nedaplatin, albumin paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate （ORR）
An objective response is defined as either a confirmed CR or a PR, as determined by the investigator using RECIST v1.1Response Evaluation Criteria in Solid Tumors (RECIST) from the National Cancer Institute (NCI).
Measured: 3 years
Progress-free survival (PFS)
Defined from date of randomization to date of first documentation of progression or death due to any cause For example, increased tumor burden (including new small lesions in non critical areas), physical fitness status, and experimentation If there is no significant deterioration in the room value, treatment is allowed to continue until at least 4 weeks later or the next planned period Repetitive imaging examination confirms disease progression at the time point of imaging examination
Measured: 1years， 2 years ， 3 years
Incidence rate of adverse events (AEs)
Analysis of adverse events (AEs) are based on treatment-related AEs (trAEs) and immune-related AEs (irAEs), and all-grade AEs and grade 3-4 AEs. AEs are evaluated by investigators according to the Common Terminology Criteria for Adverse Events, version 5.0
Measured: 3 years
Secondary outcomes (4)
Overall survival (OS)
Defined from date of randomization to date of first documentation of death from any cause or censored at the date of the last follow-up.
Measured: 1years， 2 years ， 3 years
ECOG physical fitness status
The physical condition of patients in the evaluation group was evaluated by ECOG score
Measured: Once a week for the duration of treatment, 15, 18, 21, and 24 months after completion of treatment
Tumor regression time
Measured: 3 years
Quality of Life (QOL)
Evaluate the quality of life of patients in the evaluation group through EQ-5D-5L assessment
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 posted16 May 2023
- Study start1 Jul 2021
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypopharyngeal CancerStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xinxin Zhang, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05860335
- Sponsor's protocol ID
- Interventional
- Status last verified
- Feb 2024
- First submitted
- 24 Apr 2023
- Last updated
- 20 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Geng Z, Chen N, Wei J, Liu K, Gu X, Gou X, Liang R, Wu L, Sui J, Liu L, Meng L, Ma L, Liu T, Yang S, Zhang X. Induction toripalimab plus chemotherapy sequential concurrent chemoradiotherapy with nimotuzumab followed by toripalimab maintenance in stage IVB hypopharyngeal squamous cell carcinoma: a single-arm phase 2 study. J Immunother Cancer. 2026 Jul 24;14(7):e015325. doi: 10.1136/jitc-2026-015325.
PubMed 42498484
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety ofToripalimab Combined With AP-induced Chemotherapyfollowed by Concurrent Chemoradiotherapy and Toripalimab-maintenance Therapysequentially in Patients With Non-metastatic IVB Hypopharyngeal Cancer : Aopen-lablc, Single-arm ,Phase II Clinical Study
- ClinicalTrials.gov ID
- NCT05860335
- Acronym / sponsor ID
- Interventional
- Conditions
- Hypopharyngeal Cancer
- Keywords
- non-metastatic IVB hypopharyngeal cancer, Toripalimab, Combine therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 16 May 2023 (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.
The goal of this type of study: single center exploratory clinical trial is to evaluate the efficacy and safety of Toripalimab combined with AP-induced chemotherapy followed by concurrent chemoradiotherapy and Toripalimab-maintenance therapy sequentially in patients with non-metastatic IVB hypopharyngeal cancer. The main question[s] it aims to answer are: • [main objectives: to evaluate the objective remission rate (ORR), progression-free survival (PFS) and safety of PD-1 inhibitor Toripalimab combined with induction chemotherapy (cisplatin / nedaplatin + albumin paclitaxel) in patients with locally advanced head and neck squamous cell carcinoma according to RECISTv1.1.] • [Secondary objectives: 1-year, 2-year, 3-year progression-free survival rate (PFS); 1-year, 2-year, 3-year overall survival rate (OS); overall survival time (OS); tumor regression time; quality of life was evaluated by ECOG physical status and EQ-5D-5L assessment. ] [Exploratory Objective: to explore the relationship between the biomarkers in tumor tissue and / or blood, including PD-L1 (CPS/TPS), HPV (P16), PD-1, TMB, EGFR, CD3, CD4, CD8, TP53, MSI-H and the efficacy of immunotherapy, and the relationship between MDM2/MDM4, EGFR, chromosome 11q13 interval (CCND1/FGF19/FGF3/FGF4) and immune hyperprogression] Participants will [be treated with Toripalimab injection (240mg/, once every 3 weeks) combined with cisplatin / nedaplatin (40mg) and albumin paclitaxel (230mg/m2, once every 3 weeks). The efficacy was evaluated within 1 week after induction therapy. In the phase of simultaneous radiotherapy, albumin paclitaxel (230mg/m2, once every 3 weeks, D1/D21/D43) was used. One month after the end of synchronous radiotherapy and chemotherapy, the efficacy was evaluated. After evaluation, all patients entered the next stage of immune maintenance therapy. During the maintenance phase, Toripalimabv injection (240mg/, once every 3 weeks) was given for 6 months or until the disease progressed, the toxicity was intolerable, the subjects asked to withdraw voluntarily, and the researchers judged that the subjects needed to withdraw from the study. The patients were treated with spiral tomographic radiotherapy (TOMO) or intensity modulated radiotherapy (IMRT).. These patients were given Nimotuzumab injection at the same time during simultaneous radiotherapy and chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Toripalimab +AP-induced chemotherapy | Experimental | Drug: Cisplatin/Nedaplatin, albumin paclitaxelStudy drug: toripalimab JS001 dosage：240mg Drug administration plan and mode：Intravenous infusion of 30min (not less than 20min and not more than 60min), followed by observation of 60min (only the first 2 cycles), once every 3 weeks (Q3W). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 to 70 years old
- The clinical stage was Ivb stage (AJCC 8th edition),
- ECOG score was 0-1
- Have not received any anti-tumor therapy such as radiotherapy, chemotherapy, immunotherapy or biological therapy
- No contraindications of chemotherapy, immunotherapy and radiotherapy
Key exclusion criteria (13 listed)
- Previous or simultaneous suffering from other uncured malignant tumors, except cured basal cell carcinoma of the skin, carcinoma in situ of the cervix and superficial bladder cancer
- Patients with hypopharyngeal necrosis at the same time with the risk of bleeding.
- Suffer from any active autoimmune disease or have a history of autoimmune disease (e.g. interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (can be included when hormone replacement therapy is normal). Patients with vitiligo or asthma who have been completely relieved in childhood and can be included after adulthood without any intervention, and asthma patients who need bronchodilators for medical intervention can not be included.
- Suffering from uncontrolled cardiovascular disease: myocardial ischemia or myocardial infarction of grade Ⅱ or above, poorly controlled arrhythmias (including QTc interval ≥ 470ms); cardiac insufficiency of grade Ⅲ ~ IV according to NYHA criteria, or left ventricular ejection fraction (LVEF) < 50% indicated by color Doppler ultrasound; myocardial infarction occurred within 1 year.
- There is an active infection or an unexplained fever occurs during the screening period and before the first administration of the drug > 38.5 ℃ (according to the researchers, the fever caused by the tumor can be included in the group).
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 |
|---|---|---|
| Cisplatin/Nedaplatin, albumin paclitaxelDuring induction chemotherapy, triplelimab JS001 was administered before cisplatin/Nedaplatin and albumin paclitaxel. JS001 Intravenous infusion of cisplatin/Nedaplatin was administered 60 minutes after the end of infusion and beginning on day 1 of each cycle 40mg/m 2, D1, D2 albumin paclitaxel 230 mg/m 2; Chemotherapeutic drugs are administered in accordance with the drug label and local prodrome and other standard protocols for prophylactic use, every 3 Once a week (Q3W) for 2 cycles | Drug | Toripalimab +AP-induced chemotherapy |
Primary outcome
Objective Response Rate （ORR）
Time frame: 3 years
An objective response is defined as either a confirmed CR or a PR, as determined by the investigator using RECIST v1.1Response Evaluation Criteria in Solid Tumors (RECIST) from the National Cancer Institute (NCI).
Progress-free survival (PFS)
Time frame: 1years， 2 years ， 3 years
Defined from date of randomization to date of first documentation of progression or death due to any cause For example, increased tumor burden (including new small lesions in non critical areas), physical fitness status, and experimentation If there is no significant deterioration in the room value, treatment is allowed to continue until at least 4 weeks later or the next planned period Repetitive imaging examination confirms disease progression at the time point of imaging examination
Incidence rate of adverse events (AEs)
Time frame: 3 years
Analysis of adverse events (AEs) are based on treatment-related AEs (trAEs) and immune-related AEs (irAEs), and all-grade AEs and grade 3-4 AEs. AEs are evaluated by investigators according to the Common Terminology Criteria for Adverse Events, version 5.0
4 secondary outcomes
Overall survival (OS)
Time frame: 1years， 2 years ， 3 years
ECOG physical fitness status
Time frame: Once a week for the duration of treatment, 15, 18, 21, and 24 months after completion of treatment
Tumor regression time
Time frame: 3 years
Quality of Life (QOL)
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Derived from this study: PubMed 42498484Geng Z, Chen N, Wei J, Liu K, Gu X, Gou X, Liang R, Wu L, Sui J, Liu L, Meng L, Ma L, Liu T, Yang S, Zhang X. Induction toripalimab plus chemotherapy sequential concurrent chemoradiotherapy with nimotuzumab followed by toripalimab maintenance in stage IVB hypopharyngeal squamous cell carcinoma: a single-arm phase 2 study. J Immunother Cancer. 2026 Jul 24;14(7):e015325. doi: 10.1136/jitc-2026-015325.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cisplatin/Nedaplatin, albumin paclitaxel in people with Hypopharyngeal Cancer, run by Chinese PLA General Hospital at 1 site in China.
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 7 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: status not confirmed, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xinxin Zhang (15910520109, xinxinzhang66@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate （ORR） (time frame: 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05860335, which also lists 1 linked publication.
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 20 Feb 2024.