Esophageal CancerPhase 2NCT06663059
Adebrelimab Neoadjuvant Treatment for Resectable ESCC: 2 vs 4 Cycles Study
A Phase 2 study testing Adebrelimab combined with albumin-bound paclitaxel and cisplatin 2 cycle and Adebrelimab combined with albumin-bound paclitaxel and cisplatin 4 cycle in people with Esophageal Cancer, run by Tang-Du Hospital at 1 site in China.
Trial summary
Observing the efficacy and safety of 2 cycles versus 4 cycles of Adebrelimab combined with chemotherapy as neoadjuvant treatment for patients with resectable locally advanced thoracic esophageal squamous cell carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- Adebrelimab combined with albumin-bound paclitaxel and cisplatin 2 cycle and Adebrelimab combined with albumin-bound paclitaxel and cisplatin 4 cycle
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2024to 1 Sep 2027
- 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
- Written informed consent must be signed, and the participant must voluntarily join the study.
- Histologically or cytologically confirmed esophageal squamous cell carcinoma.
- Locally advanced thoracic esophageal cancer assessed by CT/MRI/EUS, with clinical staging T1b-4aN+M0 or T2-4N0M0 (T2N0 patients must have high-risk factors such as lymphovascular invasion [LVI], tumor size ≥3 cm, or poor differentiation) (according to AJCC 8th edition).
- Expected to achieve R0 resection.
- Age between 18 and 75 years, regardless of gender.
- ECOG Performance Status 0-1.
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- No prior treatment for esophageal cancer, including radiotherapy, chemotherapy, or surgery.
- Planning to undergo surgery after completing neoadjuvant therapy.
- No contraindications for surgery.
- Normal major organ functions, including:
- Hematology (no use of blood components, growth factors, white blood cell stimulants, platelet stimulants, or anemia-correcting drugs within 14 days before the first use of the study drug):
- Neutrophil count ≥1.5 × 10^9/L
- Platelet count ≥100 × 10^9/L
- Hemoglobin ≥90 g/L
- Biochemistry:
- Total bilirubin ≤1.5 × ULN
- ALT ≤2.5 × ULN, AST ≤2.5 × ULN
- Serum creatinine ≤1.5 × ULN, or creatinine clearance ≥50 mL/min
- Coagulation:
- International Normalized Ratio (INR) ≤1.5 × ULN
- Activated Partial Thromboplastin Time (APTT) ≤1.5 × ULN
- Female participants of childbearing potential must have a negative serum pregnancy test within 72 hours before starting the study drug and must use effective contraception (e.g., intrauterine device, contraceptive pills, or condoms) during the study and for at least 3 months after the last dose. Male participants with a fertile partner must be surgically sterilized or agree to use effective contraception during the study and for 3 months after the last dose.
- Good compliance with the study and cooperation with follow-up.
Who cannot join
- Tumor clearly invading adjacent organs (e.g., major arteries or trachea).
- Supraclavicular lymph node metastasis.
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
- Poor nutritional status, BMI < 18.5 kg/m²; if corrected with symptomatic nutritional support before randomization, may be considered for inclusion after assessment by the principal investigator.
- History of allergy to monoclonal antibodies, Adebrelimab or its components, paclitaxel, cisplatin, or other platinum-based drugs.
- Previous or current treatment with:
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- Any tumor-directed radiotherapy, chemotherapy, or other anti-tumor drugs.
- Immunosuppressive drugs or systemic steroids (doses > 10 mg/day of prednisone or equivalent) within 2 weeks prior to the first use of the study drug; inhaled or topical steroids and adrenal corticosteroids for non-active autoimmune diseases are allowed.
- Live attenuated vaccines within 4 weeks prior to the first use of the study drug.
- Major surgery or severe trauma within 4 weeks prior to the first use of the study drug.
- Active autoimmune diseases or a history of autoimmune diseases, including but not limited to: interstitial pneumonia, colitis, hepatitis, pituitaryitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (considered if on hormone replacement therapy); psoriasis or childhood asthma/allergy in complete remission without intervention can be considered, but those requiring bronchodilators for medical intervention cannot be included.
- History of immunodeficiency, including positive HIV test, or other acquired or congenital immunodeficiencies, or history of organ transplantation or allogeneic bone marrow transplantation.
- Poorly controlled cardiac symptoms or diseases, including but not limited to: (1) NYHA Class II or higher heart failure, (2) unstable angina, (3) myocardial infarction within 1 year, (4) clinically significant supraventricular or ventricular arrhythmias not controlled or poorly controlled after clinical intervention.
- Severe infection (CTCAE > 2) within 4 weeks prior to the first use of the study drug, such as severe pneumonia, bacteremia, or infection complications requiring hospitalization; active pulmonary inflammation on baseline chest imaging, symptoms and signs of infection within 14 days prior to the first use of the study drug, or need for antibiotic treatment, except for prophylactic use.
- Active pulmonary tuberculosis infection discovered by medical history or CT, or history of active pulmonary tuberculosis within the past year, or history of active pulmonary tuberculosis more than 1 year ago without formal treatment.
- Active hepatitis B (HBV DNA ≥ 2000 IU/mL or 10^4 copies/mL) or hepatitis C (positive HCV antibody, and HCV RNA above the lower limit of detection).
- Diagnosis of other malignant tumors within 5 years prior to the first use of the study drug, unless it is a low-risk malignancy (5-year survival rate > 90%), such as fully treated basal cell carcinoma, squamous cell skin cancer, or cervical carcinoma in situ.
- Pregnant or breastfeeding women.
- Any condition that, in the investigator's judgment, may lead to withdrawal from the study, such as other serious illnesses (including mental illnesses) requiring concurrent treatment, alcohol or drug abuse, family or social factors that may affect the participant's safety or compliance.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tangdu Hospital Affiliated to the Fourth Military Medical University
Xi'an, Shannxi, 710038
Tao Jiang, Dr, 13572592311, jiangtaochest@163.com
About this study
Official title: A Prospective, Multicenter, Exploratory Study Comparing 2 Cycles Versus 4 Cycles of Adebrelimab Combined With Chemotherapy as Neoadjuvant Treatment for Resectable Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma
Observing the efficacy and safety of 2 cycles versus 4 cycles of Adebrelimab combined with chemotherapy as neoadjuvant treatment for patients with resectable locally advanced thoracic esophageal squamous cell carcinoma.
Read the detailed description
This study is a prospective, multicenter, exploratory clinical trial. It involves patients with resectable locally advanced thoracic esophageal squamous cell carcinoma confirmed by histopathology or cytology. The study aims to compare the efficacy and safety of 2 cycles versus 4 cycles of Adebrelimab combined with chemotherapy as neoadjuvant treatment for these patients.
Eligible patients will be randomly assigned in a 1:1 ratio to either the 2-cycle group or the 4-cycle group. The primary endpoint is pathological complete response (pCR), with a planned enrollment of 80 patients.
The study consists of a screening period (from the signing of the informed consent form to the first administration of the drug, not exceeding 21 days), a treatment period (including neoadjuvant therapy and surgery), and a follow-up period (including safety follow-up, tumor progression/recurrence follow-up, and survival follow-up).
- Conditions
- Esophageal Cancer
- Being tested
- Adebrelimab combined with albumin-bound paclitaxel and cisplatin 2 cycle, Adebrelimab combined with albumin-bound paclitaxel and cisplatin 4 cycle
- Keywords
- Esophageal Squamous Cell Carcinoma, Adebrelimab, Neoadjuvant
- Medical subject headings
- Esophageal Neoplasms, Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adebrelimab combined with albumin-bound paclitaxel and cisplatin 2 cycleDrug
Each treatment cycle is 3 weeks long (Q3W), with a total of 2 cycles. Adebrelimab: 1200 mg once on Day 1, administered intravenously, Q3W. Albumin-bound Paclitaxel: 130 mg/m² on Day 1 and Day 8, administered intravenously, Q3W.
Cisplatin: 75 mg/m² on Day 1, administered intravenously, Q3W.
Drug infusion should follow this sequence:
Adebrelimab → Albumin-bound Paclitaxel → Cisplatin, with a minimum interval of 30 minutes between each infusion.
Adebrelimab combined with albumin-bound paclitaxel and cisplatin 4 cycleDrug
Each treatment cycle is 3 weeks long (Q3W), with a total of 4 cycles. Adebrelimab: 1200 mg once on Day 1, administered intravenously, Q3W. Albumin-bound Paclitaxel: 130 mg/m² on Day 1 and Day 8, administered intravenously, Q3W.
Cisplatin: 75 mg/m² on Day 1, administered intravenously, Q3W.
Drug infusion should follow this sequence:
Adebrelimab → Albumin-bound Paclitaxel → Cisplatin, with a minimum interval of 30 minutes between each infusion.
| Study group | Role | What they receive |
|---|---|---|
| Adebrelimab combined with Chemotherapy 2 cycle | Experimental | Adebrelimab combined with albumin-bound paclitaxel and cisplatin for 2 cycles, followed by surgical resection. Receives: Drug: Adebrelimab combined with albumin-bound paclitaxel and cisplatin 2 cycle |
| Adebrelimab combined with Chemotherapy 4 cycle | Experimental | Adebrelimab combined with albumin-bound paclitaxel and cisplatin for 4 cycles, followed by surgical resection. Receives: Drug: Adebrelimab combined with albumin-bound paclitaxel and cisplatin 4 cycle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response rate(pCR)
The lack of all signs of cancer in tissue samples removed during surgery or biopsy after treatment with radiation or chemotherapy.
Measured: 7 days after surgery
Secondary outcomes (3)
Major pathologic response (MPR)
MPR is defned as less than 10% residual viable tumor after neoadjuvant therapy.
Measured: 7 days after surgery
R0 resection rate
Proportion of R0 level surgery performed.
Measured: postoperative 6 hours
Event-free survival (EFS)
The length of time after primary treatment for a caancer ends that the patient remains free of certain complicationsor events that the treatment was intended toprevent or delay.
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2024
- Study start1 Oct 2024
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by Tang-Du 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tao Jiang, Dr, Study chair, Tangdu hospital, The air force military university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06663059
- Sponsor's protocol ID
- IIT20240709
- Status last verified
- Oct 2024
- First submitted
- 25 Aug 2024
- Last updated
- 29 Oct 2024
- 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 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Exploratory Study Comparing 2 Cycles Versus 4 Cycles of Adebrelimab Combined With Chemotherapy as Neoadjuvant Treatment for Resectable Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT06663059
- Acronym / sponsor ID
- IIT20240709
- Conditions
- Esophageal Cancer
- Keywords
- Esophageal Squamous Cell Carcinoma, Adebrelimab, Neoadjuvant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 29 Oct 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.
Observing the efficacy and safety of 2 cycles versus 4 cycles of Adebrelimab combined with chemotherapy as neoadjuvant treatment for patients with resectable locally advanced thoracic esophageal squamous cell carcinoma.
Detailed description
This study is a prospective, multicenter, exploratory clinical trial. It involves patients with resectable locally advanced thoracic esophageal squamous cell carcinoma confirmed by histopathology or cytology. The study aims to compare the efficacy and safety of 2 cycles versus 4 cycles of Adebrelimab combined with chemotherapy as neoadjuvant treatment for these patients.
Eligible patients will be randomly assigned in a 1:1 ratio to either the 2-cycle group or the 4-cycle group. The primary endpoint is pathological complete response (pCR), with a planned enrollment of 80 patients.
The study consists of a screening period (from the signing of the informed consent form to the first administration of the drug, not exceeding 21 days), a treatment period (including neoadjuvant therapy and surgery), and a follow-up period (including safety follow-up, tumor progression/recurrence follow-up, and survival follow-up).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adebrelimab combined with Chemotherapy 2 cycle | Experimental | Drug: Adebrelimab combined with albumin-bound paclitaxel and cisplatin 2 cycleAdebrelimab combined with albumin-bound paclitaxel and cisplatin for 2 cycles, followed by surgical resection. |
| Adebrelimab combined with Chemotherapy 4 cycle | Experimental | Drug: Adebrelimab combined with albumin-bound paclitaxel and cisplatin 4 cycleAdebrelimab combined with albumin-bound paclitaxel and cisplatin for 4 cycles, followed by surgical resection. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Written informed consent must be signed, and the participant must voluntarily join the study.
- Histologically or cytologically confirmed esophageal squamous cell carcinoma.
- Locally advanced thoracic esophageal cancer assessed by CT/MRI/EUS, with clinical staging T1b-4aN+M0 or T2-4N0M0 (T2N0 patients must have high-risk factors such as lymphovascular invasion [LVI], tumor size ≥3 cm, or poor differentiation) (according to AJCC 8th edition).
- Expected to achieve R0 resection.
- Age between 18 and 75 years, regardless of gender.
Key exclusion criteria (19 listed)
- Tumor clearly invading adjacent organs (e.g., major arteries or trachea).
- Supraclavicular lymph node metastasis.
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
- Poor nutritional status, BMI < 18.5 kg/m²; if corrected with symptomatic nutritional support before randomization, may be considered for inclusion after assessment by the principal investigator.
- History of allergy to monoclonal antibodies, Adebrelimab or its components, paclitaxel, cisplatin, or other platinum-based drugs.
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 |
|---|---|---|
| Adebrelimab combined with albumin-bound paclitaxel and cisplatin 2 cycleEach treatment cycle is 3 weeks long (Q3W), with a total of 2 cycles. Adebrelimab: 1200 mg once on Day 1, administered intravenously, Q3W. Albumin-bound Paclitaxel: 130 mg/m² on Day 1 and Day 8, administered intravenously, Q3W. Cisplatin: 75 mg/m² on Day 1, administered intravenously, Q3W. Drug infusion should follow this sequence: Adebrelimab → Albumin-bound Paclitaxel → Cisplatin, with a minimum interval of 30 minutes between each infusion. | Drug | Adebrelimab combined with Chemotherapy 2 cycle |
| Adebrelimab combined with albumin-bound paclitaxel and cisplatin 4 cycleEach treatment cycle is 3 weeks long (Q3W), with a total of 4 cycles. Adebrelimab: 1200 mg once on Day 1, administered intravenously, Q3W. Albumin-bound Paclitaxel: 130 mg/m² on Day 1 and Day 8, administered intravenously, Q3W. Cisplatin: 75 mg/m² on Day 1, administered intravenously, Q3W. Drug infusion should follow this sequence: Adebrelimab → Albumin-bound Paclitaxel → Cisplatin, with a minimum interval of 30 minutes between each infusion. | Drug | Adebrelimab combined with Chemotherapy 4 cycle |
Primary outcome
Pathological complete response rate(pCR)
Time frame: 7 days after surgery
The lack of all signs of cancer in tissue samples removed during surgery or biopsy after treatment with radiation or chemotherapy.
3 secondary outcomes
Major pathologic response (MPR)
Time frame: 7 days after surgery
R0 resection rate
Time frame: postoperative 6 hours
Event-free survival (EFS)
Time frame: up to 2 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 29 Oct 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.
Tao Jiang, Dr study chair
Tangdu hospital, The air force military university
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 Adebrelimab combined with albumin-bound paclitaxel and cisplatin 2 cycle and Adebrelimab combined with albumin-bound paclitaxel and cisplatin 4 cycle in people with Esophageal Cancer, run by Tang-Du 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 23 inclusion and 19 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: looking for participants now, as of the sponsor's last update on 29 Oct 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?
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 Tao Jiang, Dr (13572592311, jiangtaochest@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete response rate(pCR) (time frame: 7 days after surgery). 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 29 Oct 2024.