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New treatment option for Early-Stage Oral Squamous Cell Carcinoma
Official title Neoadjuvant Low-Dose Radiotherapy Combined With Adebrelimab and Single-Agent Albumin-Bound Paclitaxel Chemotherapy for Early-Stage Oral Squamous Cell Carcinoma: A Prospective, Single-Arm Clinical Trial
ClinicalTrials.gov ID: NCT07007364
What this study is testing
What is Adebrelimab Combined With Albumin Paclitaxel?
Adebrelimab Combined With Albumin Paclitaxel is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for early-stage oral squamous cell carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a prospective, single-arm, Phase II clinical trial. The included population consisted of untreated patients with histologically confirmed stage I-II oral squamous cell carcinoma.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Patients aged 18 to 70, gender not limited;
- Confirmed by pathological examination as oral squamous cell carcinoma (anterior 2/3 of the tongue, floor of the mouth, gingiva, buccal mucosa, hard...
- Diagnosed as stage I-II oral squamous cell carcinoma (T1-2N0M0) according to the 8th edition of the clinical staging system of the American Joint...
- ECOG 0-1 point;
- Vital organs function normally and can tolerate the prescribed treatment plan:
You likely can't join if
- 1\. There is uncontrollable pleural effusion, pericardial effusion or peritoneal effusion that requires repeated drainage; 2. There is a history of...
- Having received any other investigational drugs within 4 weeks before the first use of the investigational drug or no more than 5 half-lives from the...
- Enroll in another clinical study simultaneously, unless it is an observational (non-treatment) clinical study or follow-up of an treatment clinical...
- Have received anti-tumor treatment (including radiotherapy, chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biological therapy or...
- people who need to be given corticosteroids (an equivalent dose of \> 10 mg prednisone per day) within 2 weeks before the first use of the study...
- Those who have received anti-tumor vaccines or those who have received live vaccines within 4 weeks before the first administration of the study drug;
See the full eligibility criteria
- Patients aged 18 to 70, gender not limited;
- Confirmed by pathological examination as oral squamous cell carcinoma (anterior 2/3 of the tongue, floor of the mouth, gingiva, buccal mucosa, hard palate, posterior molar area);
- Diagnosed as stage I-II oral squamous cell carcinoma (T1-2N0M0) according to the 8th edition of the clinical staging system of the American Joint Committee on Cancer;
- ECOG 0-1 point;
- Vital organs function normally and can tolerate the prescribed treatment plan:
- There was no obvious abnormality in bone marrow hematopoietic function before treatment: white blood cell count ≥3.5×109/L, neutrophil count ≥2.0×109/L; Hemoglobin ≥100g/L Platelet count ≥100×109/L;
- No obvious abnormalities were observed in liver and kidney functions before treatment: Total bilirubin ≤1.5 times the upper limit of normal; Aspartate aminotransferase and/or alanine aminotransferase ≤2.5 times the...
- The examination results of thyroid function, coagulation function, pituitary function, inflammatory infection indicators, myocardial enzymes, electrocardiogram and echocardiography are normal;
- Women of childbearing age (18-49 years old) have negative serum or urine HCG tests within 7 days before treatment and agree to use medically approved contraceptive measures during the treatment period and within 120...
- Sign the informed consent form, voluntarily participate in the clinical trial research project, and be willing and able to comply with the follow-up, treatment, laboratory testing and other research requirements...
- 1\. There is uncontrollable pleural effusion, pericardial effusion or peritoneal effusion that requires repeated drainage; 2. There is a history of allergy to adbelimab in the past; 3. Has received any of the following...
- Having received any other investigational drugs within 4 weeks before the first use of the investigational drug or no more than 5 half-lives from the last investigational drug use;
- Enroll in another clinical study simultaneously, unless it is an observational (non-treatment) clinical study or follow-up of an treatment clinical study;
- Have received anti-tumor treatment (including radiotherapy, chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biological therapy or tumor embolization) within 2 weeks before the first use of the study...
- people who need to be given corticosteroids (an equivalent dose of \> 10 mg prednisone per day) within 2 weeks before the first use of the study drug. Hormones are allowed for routine chemotherapy pretreatment without...
- Those who have received anti-tumor vaccines or those who have received live vaccines within 4 weeks before the first administration of the study drug;
- Underwent major surgery or suffered severe trauma within 4 weeks before the first use of the study drug;
- Patients who have previously received treatment with taxanes; 4. The toxicity of previous anti-tumor treatments has not recovered to ≤CTCAE 5.0 grade 1 (except for alopecia) or the level specified in the...
The study team makes the final eligibility decision.
Where it's taking place
- Wuhan, Hubei, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wuhan, Hubei, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.