Neoadjuvant Therapy of Operable Locally Advanced Head and Neck Squamous Cell CarcinomaPhase 2NCT06537011
AK112 Plus AP Regimen for Operable Locally Advanced Head and Neck Squamous Cell Carcinoma
A Phase 2 study testing AK112 in people with Neoadjuvant Therapy of Operable Locally Advanced Head and Neck Squamous Cell Carcinoma, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology.
Trial summary
This exploratory phase II study is designed to enroll patients with operable locally advanced head and neck squamous cell carcinoma, to observe the efficacy and safety of AK112 combined with chemotherapy as neoadjuvant therapy on them. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Neoadjuvant Therapy of Operable Locally Advanced Head and Neck Squamous Cell Carcinoma
- What is being tested?
- AK112
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2024to 30 Jul 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-70 years, regardless of sex;
- histological diagnosis of squamous cell carcinoma in oral cavity,oropharynx, hypopharynx or laryngeal;
- preoperative evaluation turns to be operatable;
- locally advanced, according to the American Joint Committee on Cancer ( AJCC -RSB- guidelines, 8th edition),HPV status is determined by p16 immunohistochemistry (IHC);
- Have not received prior treatment for head and neck squamous cell carcinoma;
- Have at least one evaluable target lesion according to RECIST version 1.1;
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- ECOG physical condition 0-1 point;
- The function of the major organs is normal, which meets the following criteria(not receiving blood transfusion in 14 days):
- Hb(hemoglobin)≥90g/L:b. ANC(Neutrophils)≥1.5x109/L; c. PLT(platelet)≥80x109／L；
- The biochemical tests should meet the following criteria:
- a.BIL(bilirubin)< 1.25 times the upper limit of normal (ULN); b.ALT(Alanine aminotransferase) and AST(Aspartate aminotransferase)<2.5xULN; c.Serum CR(creatinine) ≤ ULN, endogenous creatinine clearance > 50 ml/min (Cockcroft-Gaut formula) ;
- Sign a written informed consent form before performing any test related activities;
- The researchers judged that they were able to comply with the study protocol;
- Pregnancy test (for fertile women) was negative at screening;
- Fertile male patients as well as fertile female patients at risk of fertility and pregnancy had to agree to use 2 contraceptive methods throughout the study period (at least one of which was considered to be an efficient contraceptive method) .
- Patients who are willing and able to follow visiting schedules, treatment plans, laboratory tests, and other research procedures.
Who cannot join
- Previously received immunotherapy with anti-PD-1(programmed cell death receptor-1), anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibodies (including ipilimumab) or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways;
- Previously received prior chemotherapy or antiangiogenic therapy;
- Received major surgery ≤4 weeks before admission;
- Carrying any active autoimmune disease or history of autoimmune disease'
- Previous or concurrent getting cancers (except those that have been cured and have survived cancer-free for more than 5 years, such as skin basal-cell carcinoma, cervical carcinoma in situ, and papillary thyroid cancer) .
- Uncontrollable clinical symptom or disease of the heart;
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- Within 14 days before the administration of the study drug, subjects who were required to undergo systemic therapy with corticosteroid (> 10 mg daily prednisone efficacy dose) or other immunosuppressive agents, in the absence of active autoimmune disease, adrenal hormone replacement with inhaled or topical steroids and a therapeutic dose of prednisone > 10 mg/day was allowed;
- Active infection requiring treatment;
- Patients with congenital or acquired immunodeficiency(such as HIV),active hepatitis B (HBV-DNA ≥104 copies/ml or 2000 IU/ml) , or hepatitis C (HCV-RNA was above the lower limit of detection);
- The patient has received other cancer specialised treatment;
- The live vaccine was administered within 4 weeks before starting the study;
- Known history of psychotropic substance abuse, alcohol or drug abuse;
- Pregnant or lactating female;
- The researchers determined that the subjects had other factors that could have led them to stop the study mid-course, such as having a serious medical condition (including mental illness) that required combined treatment, and severe abnormalities in laboratory tests, family or social factors that may affect the safety of the subject or the collection of experimental data;
- A patient who is considered by the surgeon to be inoperable;
- Active tuberculosis;
- Severe infections (including, but not limited to, hospitalizations for infections, bacteremia, or complications of severe pneumonia) occurring within 4 weeks before study initiation;
- Received systemic immunostimulatory medication (including but not limited to interferon or interleukin-2[ IL-2]) within 4 weeks before initiation of study treatment or remained within 5 drug half-lives (taking the older of the two) .
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: An Exploratory Phase II Study of Neoadjuvant Treatment With AK112 Plus AP Regimen for Operable Locally Advanced Head and Neck Squamous Cell Carcinoma
This exploratory phase II study is designed to enroll patients with operable locally advanced head and neck squamous cell carcinoma, to observe the efficacy and safety of AK112 combined with chemotherapy as neoadjuvant therapy on them.
Read the detailed description
This exploratory phase II study is designed to enroll 36 patients with operable locally advanced head and neck squamous cell carcinoma(defined according to 8th teh edition of AJCC Guideline). The patients are given 3cycles of AK112(20mg/Kg per cycle) combined with AP regimen(platinum based chemotherapy), with a 3-week interval between each cycle (d1,d22,d43). After 3 cycles' therapy, if the volume of primary tumor decreases by over 50%，the range of resection operation will be conducted by the actual range of tumor, or else the surgery will be conducted by the original range of the tumor. The adjuvant radiation therapy would be conducted in 4-6 weeks after the surgery, while the adjuvant therapy of AK112 would be given in 21days after the surgery for 14 cycles. The process will continue until disease progression or uncontrolled toxicity. The primary endpoint is pCR(pathological complete response) and 2y-EFS; the secondary endpoint is MPR(Main pathological response)、ORR(objective response rate)、2y-OS(overall survival)、organ retention rate and safety assessment.
- Being tested
- AK112
- Keywords
- neoadjuvant therapy,AK112,advanced head and neck squamous cell carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AK112Drug
- The patients are given AK112 combined with AP regimen every 3 weeks for 3 cycles before operation.
- After the neoadjuvant therapy ,the patients will be assessed and be commanded surgery.
3.4-6 weeks after the surgery, the patients will be given chemoradiotherapy or radiotherapy alone decided on the conditon after surgery.
4.The participants will receive AK112 for 14 cycles after surgery.
| Study group | Role | What they receive |
|---|---|---|
| AK112 combined with AP neoadjuvant therapy | Experimental | Three cycles of AK112 were given before operation every 3 weeks on D 1, D 22 and D 43, while AP regimen was given every 3 weeks on D 1, D 22 and D 43, respectively. Receives: Drug: AK112 |
What is being measured
The primary outcome is the main question the study is designed to answer.
EFS
The time between the onset of treatment till disease progression, discontinuation of treatment for any reason, or death
Measured: 2 years
Secondary outcomes (3)
pCR
The percentage of tumor tissue that has completely disappeared on pathological examination after treatment
Measured: 3 cycles of treatment(1.5months)
OS
The time between the onset of treatment till death
Measured: 2 years
MPR
The percentage of active tumor components decreasing below a certain threshold
Measured: 3 cycles of treatment(1.5months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2024
- Study start1 Aug 2024 (estimated)
- Primary completion15 Jul 2027 (estimated)
- Study completion30 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoadjuvant Therapy of Operable Locally Advanced Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe 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
- 36 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06537011
- Sponsor's protocol ID
- AK112-II-020
- Status last verified
- Jul 2024
- First submitted
- 31 Jul 2024
- Last updated
- 6 Aug 2024
- Results posted
- No
- 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 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Phase II Study of Neoadjuvant Treatment With AK112 Plus AP Regimen for Operable Locally Advanced Head and Neck Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT06537011
- Acronym / sponsor ID
- AK112-II-020
- Keywords
- neoadjuvant therapy,AK112,advanced head and neck squamous cell carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 15 Jul 2027 (estimated)
- Study completion
- 30 Jul 2028 (estimated)
- First posted
- 5 Aug 2024 (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.
This exploratory phase II study is designed to enroll patients with operable locally advanced head and neck squamous cell carcinoma, to observe the efficacy and safety of AK112 combined with chemotherapy as neoadjuvant therapy on them.
Detailed description
This exploratory phase II study is designed to enroll 36 patients with operable locally advanced head and neck squamous cell carcinoma(defined according to 8th teh edition of AJCC Guideline). The patients are given 3cycles of AK112(20mg/Kg per cycle) combined with AP regimen(platinum based chemotherapy), with a 3-week interval between each cycle (d1,d22,d43). After 3 cycles' therapy, if the volume of primary tumor decreases by over 50%，the range of resection operation will be conducted by the actual range of tumor, or else the surgery will be conducted by the original range of the tumor. The adjuvant radiation therapy would be conducted in 4-6 weeks after the surgery, while the adjuvant therapy of AK112 would be given in 21days after the surgery for 14 cycles. The process will continue until disease progression or uncontrolled toxicity. The primary endpoint is pCR(pathological complete response) and 2y-EFS; the secondary endpoint is MPR(Main pathological response)、ORR(objective response rate)、2y-OS(overall survival)、organ retention rate and safety assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AK112 combined with AP neoadjuvant therapy | Experimental | Drug: AK112Three cycles of AK112 were given before operation every 3 weeks on D 1, D 22 and D 43, while AP regimen was given every 3 weeks on D 1, D 22 and D 43, respectively. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Age 18-70 years, regardless of sex;
- histological diagnosis of squamous cell carcinoma in oral cavity,oropharynx, hypopharynx or laryngeal;
- preoperative evaluation turns to be operatable;
- locally advanced, according to the American Joint Committee on Cancer ( AJCC -RSB- guidelines, 8th edition),HPV status is determined by p16 immunohistochemistry (IHC);
- Have not received prior treatment for head and neck squamous cell carcinoma;
Key exclusion criteria (18 listed)
- Previously received immunotherapy with anti-PD-1(programmed cell death receptor-1), anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibodies (including ipilimumab) or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways;
- Previously received prior chemotherapy or antiangiogenic therapy;
- Received major surgery ≤4 weeks before admission;
- Carrying any active autoimmune disease or history of autoimmune disease'
- Previous or concurrent getting cancers (except those that have been cured and have survived cancer-free for more than 5 years, such as skin basal-cell carcinoma, cervical carcinoma in situ, and papillary thyroid cancer) .
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 |
|---|---|---|
| AK1121. The patients are given AK112 combined with AP regimen every 3 weeks for 3 cycles before operation. 2. After the neoadjuvant therapy ,the patients will be assessed and be commanded surgery. 3.4-6 weeks after the surgery, the patients will be given chemoradiotherapy or radiotherapy alone decided on the conditon after surgery. 4.The participants will receive AK112 for 14 cycles after surgery. | Drug | AK112 combined with AP neoadjuvant therapy |
Primary outcome
EFS
Time frame: 2 years
The time between the onset of treatment till disease progression, discontinuation of treatment for any reason, or death
3 secondary outcomes
pCR
Time frame: 3 cycles of treatment(1.5months)
OS
Time frame: 2 years
MPR
Time frame: 3 cycles of treatment(1.5months)
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 6 Aug 2024.
- 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 AK112 in people with Neoadjuvant Therapy of Operable Locally Advanced Head and Neck Squamous Cell Carcinoma, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology.
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 16 inclusion and 18 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 6 Aug 2024. 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 kunyu yang, doctor (13429829986, wenlu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EFS (time frame: 2 years). 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 6 Aug 2024.