Mouth NeoplasmsPhase 2NCT06848439
Benmelstobart-Anlotinib-Chemo for Neoadjuvant Oral Cancer
A Phase 2 study testing benmelstobart-Anlotinib-Chemo in people with Mouth Neoplasms and Neoadjuvant Therapy, run by Jiangsu Cancer Institute & Hospital at 1 site in China.
Trial summary
Exploring the Safety and Efficacy of Benmelstobart Combined with Anlotinib and Chemotherapy as Neoadjuvant Therapy Followed by Surgery and Postoperative Radiotherapy in Patients with Locally Advanced Oral Cancer This is a single-center, Phase II study targeting patients with stage III-IVb locally advanced oral… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Mouth Neoplasms, Neoadjuvant Therapy, Immunotherapy
- What is being tested?
- benmelstobart-Anlotinib-Chemo
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Potential subjects must meet all of the following criteria to be eligible for inclusion in this study:
- Age 18-75 years;
- ECOG PS score of 0-1;
- Pathologically confirmed untreated oral squamous cell carcinoma patients, classified as stage III-IVb according to the AJCC (8th edition) staging system;
- Women of childbearing potential must have taken reliable contraceptive measures or have a negative pregnancy test (serum or urine) within 7 days prior to enrollment, and be willing to use appropriate contraceptive methods during the trial and for 8 weeks after the last dose of the study drug, or be surgically sterilized. For men, they must agree to use appropriate contraceptive methods during the trial and for 8 weeks after the last dose of the study drug, or be surgically sterilized;
- Signed informed consent form by the participant, with good compliance.
Who cannot join
- Potential subjects must be excluded from the study if they meet any of the following criteria:
- Prior treatment with PD-1/PD-L1/CTLA-4 antibodies.
- Tumor invasion of major blood vessels.
- Requirement for systemic corticosteroid therapy (>10 mg prednisone equivalent per day) or other immunosuppressive treatment within 14 days before administration or during treatment. Inhaled or topical steroids and adrenal corticosteroid replacement therapy at ≤10 mg/day prednisone equivalent are allowed in the absence of active autoimmune disease.
- History of any active immune-related or autoimmune disease, or a known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
- Active or uncontrolled severe infection (≥ Grade 2 NCI CTCAE v5.0 infection) within 4 weeks prior to enrollment.
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- Coagulation disorders (INR >1.5, prothrombin time (PT) > ULN + 4 sec, or APTT >1.5 × ULN), a tendency for bleeding, or undergoing thrombolytic or anticoagulant therapy. Note: The use of low-dose heparin (adult daily dose of 6,000-12,000 U) or low-dose aspirin (daily dose ≤100 mg) for prophylactic purposes is allowed if INR ≤1.5.
- Imaging evidence of tumor invasion of major blood vessels or tumors highly likely to invade major blood vessels and cause fatal hemorrhage during the study, as assessed by the investigator.
- Any signs or history of a bleeding tendency, regardless of severity. Patients with bleeding or hemorrhagic events (≥CTCAE Grade 2) within 4 weeks prior to randomization, or those with unhealed wounds, ulcers, or fractures.
- Major organ dysfunction:
- Hematological abnormalities (without correction via blood transfusion, blood products, G-CSF, or other hematopoietic stimulants within 14 days):
- Hemoglobin (HB) <90 g/L.
- Absolute neutrophil count (ANC) <1.5 × 10⁹/L.
- Platelets (PLT) <100 × 10⁹/L.
- Biochemical abnormalities:
- Total bilirubin (TBIL) >1.5 × ULN.
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) >2.5 × ULN.
- Serum creatinine (Cr) >1.5 × ULN or creatinine clearance rate (CCr) <60 mL/min. Doppler ultrasound abnormalities: Left ventricular ejection fraction (LVEF) <60%.
- Thyroid function abnormalities: TSH > ULN with abnormal T3 and T4 levels. Renal dysfunction: Urine protein ≥++ on urinalysis or confirmed 24-hour urine protein level ≥1.0 g.
- History of myocardial ischemia (≥Grade I), myocardial infarction, arrhythmia (QTc ≥480 ms), or ≥Grade 2 congestive heart failure (NYHA classification) within 6 months before enrollment.
- Diagnosis of another malignancy within 3 years prior to enrollment.
- Any severe and/or uncontrolled disease, including:
- Poorly controlled hypertension (systolic BP ≥150 mmHg or diastolic BP ≥100 mmHg), history of myocardial ischemia (≥Grade I), myocardial infarction, arrhythmia (QT interval ≥430 ms), or heart failure (NYHA Grade I).
- Active or uncontrolled severe infection.
- Liver cirrhosis, decompensated liver disease, or active hepatitis (HBV or HCV).
- Poorly controlled diabetes (fasting blood glucose (FBG) >10 mmol/L).
- Urine protein ≥2+ and confirmed 24-hour urine protein >1.0 g.
- Presence of long-term unhealed wounds or fractures.
- Lung hemorrhage (>Grade 1 NCI CTC AE v4.0) within 4 weeks before enrollment or hemorrhage in other areas (>Grade 2 NCI CTC AE v4.0) within 4 weeks before enrollment. Patients with a tendency to bleed (e.g., active gastrointestinal ulcers) or those receiving thrombolytic or anticoagulant therapy (e.g., warfarin, heparin, or similar agents).
- History of gastrointestinal perforation and/or fistula within 6 months before treatment initiation; or history of arterial/venous thrombotic events, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism.
- Imaging evidence of tumor invasion of major blood vessels or tumors highly likely to invade major blood vessels and cause fatal hemorrhage, as assessed by the investigator.
- Clinically significant ascites, including any detectable ascites on physical examination or ascites requiring treatment. Patients with only mild asymptomatic ascites detected by imaging may be enrolled.
- Uncontrolled metabolic disorders or other non-malignant systemic diseases or conditions secondary to cancer that may pose a high medical risk and/or create uncertainty in survival assessment.
- Participation in other anti-tumor clinical trials within 4 weeks prior to enrollment.
- History of substance abuse that cannot be discontinued or the presence of psychiatric disorders.
- Any other conditions determined by the investigator that may pose serious risks to patient safety, confound study results, or affect the patient's ability to complete the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Xiaomeng Song, Doctor of Medicine contact
China1 site
Affiliated Stomatological Hospital of Nanjing Medical University
Nanjing, Jiangsu
Xiaomeng Song, Doctor, +8615261410357, sxm2081@163.com
About this study
Official title: A Phase II Study of Benmelstobart Combined With Anlotinib and Chemotherapy as Neoadjuvant Therapy Followed by Surgery and Postoperative Radiotherapy in Patients With Locally Advanced Oral Cancer
Exploring the Safety and Efficacy of Benmelstobart Combined with Anlotinib and Chemotherapy as Neoadjuvant Therapy Followed by Surgery and Postoperative Radiotherapy in Patients with Locally Advanced Oral Cancer
This is a single-center, Phase II study targeting patients with stage III-IVb locally advanced oral squamous cell carcinoma who meet the inclusion and exclusion criteria. The neoadjuvant therapy consists of Benmelstobart combined with Anlotinib and chemotherapy for 3 cycles (21 days per cycle). Surgery is performed within 2 weeks after completing neoadjuvant therapy. Postoperative adjuvant treatment is selected based on pathological grading:
Read more
Group A (Pathological Complete Response, pCR): Postoperative radiotherapy (RT) alone: 40Gy/5 weeks.
Group B (Major Pathological Response, MPR): Postoperative radiotherapy (RT) alone: 50Gy/5 weeks.
Group C (Partial Pathological Response/No Pathological Response):
Low-to-intermediate risk patients (no extracapsular nodal extension and negative margins): RT: 60Gy/6 weeks.
High-risk patients (extracapsular nodal extension and/or positive margins): Concurrent chemoradiotherapy (CCRT): 60-66Gy/6-6.6 weeks + Cisplatin: 60mg/m² every 3 weeks, 2-3 cycles.
Additionally, all patients will receive adjuvant Benmelstobart 3-4 weeks after surgery, followed by Benmelstobart maintenance therapy (total treatment duration of 1 year).
- Being tested
- benmelstobart-Anlotinib-Chemo
- Keywords
- Mouth Neoplasms, Neoadjuvant therapy, Immunotherapy, Molecular Targeted Therapy
- Medical subject headings
- Mouth Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
benmelstobart-Anlotinib-ChemoDrug
Neoadjuvant Treatment Regimen :
Benmelstobart: 1200mg, Day 1, IV (21 days per cycle); Anlotinib: 10mg, Days 1-14, orally (21 days per cycle); Cisplatin: 60mg/m², Day 1, IV (21 days per cycle); Albumin-bound Paclitaxel: 260mg/m², IV infusion, Day 1 (21 days per cycle). Total of 3 cycles.
Surgery is performed within 2 weeks after completing neoadjuvant therapy. Postoperative adjuvant treatment is selected based on pathological grading:
Group A (pCR): Postoperative RT alone: 40Gy/5 weeks. Group B (MPR): Postoperative RT alone: 50Gy/5 weeks. Group C (partial pathological response/no pathological response) : low and intermediate-risk patients: RT: 60Gy/6w; High-risk patients: CCRT: 60-66Gy/6-6.6w + cisplatin: 60mg/m2 Q3W, 2-3 cycles.
All patients also received adjuvant Benmelstobart 3-4 weeks after surgery, as well as maintenance Benmelstobart for a total duration of 1 year.
| Study group | Role | What they receive |
|---|---|---|
| Benmelstobart-Anlotinib-Chemo | Experimental | Not described Receives: Drug: benmelstobart-Anlotinib-Chemo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival at 2 years, DFS
Measured: Two years after enrollment
Secondary outcomes (6)
ORR
Objective Response Rate (ORR) as per RECIST 1.1 Criteria
Measured: Ten weeks after enrollment (after completion of neoadjuvant therapy)
Major pathological response, MPR
Measured: Twelve weeks after enrollment (after neoadjuvant therapy and surgery)
pCR
Pathological complete response (pCR) rate; It was defined as the presence of 0% viable tumor on pathological examination of the tissue specimen
Measured: Twelve weeks after enrollment (after neoadjuvant therapy and surgery)
LRFS at 2 years
Locoregional Recurrence-Free Survival (LRFS)
Measured: Two years after enrollment
DMFS at 2 years
Distant Metastasis-Free Survival(DMFS)
Measured: Two years after enrollment
OS at 2 years
Overall Survival(OS)
Measured: Two years after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start15 Jun 2025 (estimated)
- Primary completion31 Dec 2027 (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 Mouth NeoplasmsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Cancer Institute & Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu Provincial Stomatological Hospital
- Responsible party
- Principal investigator, Lirong Wu, Jiangsu Cancer Institute & Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06848439
- Sponsor's protocol ID
- BENMEL-ANLO-CHEMO-II
- Status last verified
- May 2025
- First submitted
- 16 Feb 2025
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Protecting patient privacy
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Benmelstobart Combined With Anlotinib and Chemotherapy as Neoadjuvant Therapy Followed by Surgery and Postoperative Radiotherapy in Patients With Locally Advanced Oral Cancer
- ClinicalTrials.gov ID
- NCT06848439
- Acronym / sponsor ID
- BENMEL-ANLO-CHEMO-II
- Keywords
- Mouth Neoplasms, Neoadjuvant therapy, Immunotherapy, Molecular Targeted Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Jiangsu Cancer Institute & HospitalUniversity, hospital or other
- Collaborators
- Jiangsu Provincial Stomatological Hospital
- Study start
- 15 Jun 2025 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 27 Feb 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.
Exploring the Safety and Efficacy of Benmelstobart Combined with Anlotinib and Chemotherapy as Neoadjuvant Therapy Followed by Surgery and Postoperative Radiotherapy in Patients with Locally Advanced Oral Cancer
This is a single-center, Phase II study targeting patients with stage III-IVb locally advanced oral squamous cell carcinoma who meet the inclusion and exclusion criteria. The neoadjuvant therapy consists of Benmelstobart combined with Anlotinib and chemotherapy for 3 cycles (21 days per cycle). Surgery is performed within 2 weeks after completing neoadjuvant therapy. Postoperative adjuvant treatment is selected based on pathological grading:
Group A (Pathological Complete Response, pCR): Postoperative radiotherapy (RT) alone: 40Gy/5 weeks.
Group B (Major Pathological Response, MPR): Postoperative radiotherapy (RT) alone: 50Gy/5 weeks.
Group C (Partial Pathological Response/No Pathological Response):
Low-to-intermediate risk patients (no extracapsular nodal extension and negative margins): RT: 60Gy/6 weeks.
High-risk patients (extracapsular nodal extension and/or positive margins): Concurrent chemoradiotherapy (CCRT): 60-66Gy/6-6.6 weeks + Cisplatin: 60mg/m² every 3 weeks, 2-3 cycles.
Additionally, all patients will receive adjuvant Benmelstobart 3-4 weeks after surgery, followed by Benmelstobart maintenance therapy (total treatment duration of 1 year).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Benmelstobart-Anlotinib-Chemo | Experimental | Drug: benmelstobart-Anlotinib-Chemo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Potential subjects must meet all of the following criteria to be eligible for inclusion in this study:
- Age 18-75 years;
- ECOG PS score of 0-1;
- Pathologically confirmed untreated oral squamous cell carcinoma patients, classified as stage III-IVb according to the AJCC (8th edition) staging system;
- Women of childbearing potential must have taken reliable contraceptive measures or have a negative pregnancy test (serum or urine) within 7 days prior to enrollment, and be willing to use appropriate contraceptive methods during the trial and for 8 weeks after the last dose of the study drug, or be surgically sterilized. For men, they must agree to use appropriate contraceptive methods during the trial and for 8 weeks after the last dose of the study drug, or be surgically sterilized;
Key exclusion criteria (36 listed)
- Potential subjects must be excluded from the study if they meet any of the following criteria:
- Prior treatment with PD-1/PD-L1/CTLA-4 antibodies.
- Tumor invasion of major blood vessels.
- Requirement for systemic corticosteroid therapy (>10 mg prednisone equivalent per day) or other immunosuppressive treatment within 14 days before administration or during treatment. Inhaled or topical steroids and adrenal corticosteroid replacement therapy at ≤10 mg/day prednisone equivalent are allowed in the absence of active autoimmune disease.
- History of any active immune-related or autoimmune disease, or a known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
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 |
|---|---|---|
| benmelstobart-Anlotinib-ChemoNeoadjuvant Treatment Regimen : Benmelstobart: 1200mg, Day 1, IV (21 days per cycle); Anlotinib: 10mg, Days 1-14, orally (21 days per cycle); Cisplatin: 60mg/m², Day 1, IV (21 days per cycle); Albumin-bound Paclitaxel: 260mg/m², IV infusion, Day 1 (21 days per cycle). Total of 3 cycles. Surgery is performed within 2 weeks after completing neoadjuvant therapy. Postoperative adjuvant treatment is selected based on pathological grading: Group A (pCR): Postoperative RT alone: 40Gy/5 weeks. Group B (MPR): Postoperative RT alone: 50Gy/5 weeks. Group C (partial pathological response/no pathological response) : low and intermediate-risk patients: RT: 60Gy/6w; High-risk patients: CCRT: 60-66Gy/6-6.6w + cisplatin: 60mg/m2 Q3W, 2-3 cycles. All patients also received adjuvant Benmelstobart 3-4 weeks after surgery, as well as maintenance Benmelstobart for a total duration of 1 year. | Drug | Benmelstobart-Anlotinib-Chemo |
Primary outcome
Disease-free survival at 2 years, DFS
Time frame: Two years after enrollment
6 secondary outcomes
ORR
Time frame: Ten weeks after enrollment (after completion of neoadjuvant therapy)
Major pathological response, MPR
Time frame: Twelve weeks after enrollment (after neoadjuvant therapy and surgery)
pCR
Time frame: Twelve weeks after enrollment (after neoadjuvant therapy and surgery)
LRFS at 2 years
Time frame: Two years after enrollment
DMFS at 2 years
Time frame: Two years after enrollment
OS at 2 years
Time frame: Two years after enrollment
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 31 May 2025.
- Individual participant dataSharing planned: No. Protecting patient privacy
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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.
Xiaomeng Song, Doctor of Medicine contact
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 benmelstobart-Anlotinib-Chemo in people with Mouth Neoplasms and Neoadjuvant Therapy, run by Jiangsu Cancer Institute & 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 6 inclusion and 36 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 31 May 2025. 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?
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 Lirong Wu, Doctor of Medicine (86+13701588737, wulirong126@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free survival at 2 years, DFS (time frame: Two years after enrollment). 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 31 May 2025.