Esophageal Cancer (EsC)Phase 2NCT06869213
A Single-arm, Open, Single-center Exploratory Study of Adebrelimab (SHR-1316) in Combination With Chemotherapy for the Perioperative Treatment of Locally Advanced Resectable Esophageal Squamous Carcinoma
A Phase 2 study testing Adebrelimab (SHR-1316) + Nab-paclitaxel + Cisplatin in people with Esophageal Cancer (EsC), run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial summary
This study is a prospective, observational clinical study. In this study, 30 patients with resectable locally advanced esophageal squamous carcinoma will be prospectively enrolled and treated with adebrelimab (SHR-1316) combined with nab-paclitaxel and cisplatin preoperatively and adebrelimab (SHR-1316) single-agent… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Cancer (EsC)
- What is being tested?
- Adebrelimab (SHR-1316) + Nab-paclitaxel + Cisplatin
- 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
- 31 Mar 2025to 31 Dec 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
- Aged 18-75 years old, regardless of gender；
- Surgically resectable locally advanced squamous cell carcinoma of the esophagus confirmed by histology or cytology (pre-treatment clinical stage cT1b-cT2, N+ or cT3-cT4a, ANY N according to the 8th edition of AJCC staging);
- Presence of measurable and/or non-measurable lesions as defined by the criteria for evaluating the efficacy of solid tumors (RECIST v1.1);
- No prior antitumor therapy for esophageal cancer, including chemotherapy, radiotherapy (including planned radiotherapy during the study period), hormone therapy, and immunotherapy;
- ECOG PS 0 to 1 point;
- No contraindication to surgery as evaluated by various organ function tests;
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- Prior to treatment, the following laboratory tests to confirm that bone marrow, liver and kidney function meet the requirements for participation in the study (requiring no blood transfusion or use of hematopoietic stimulating factors (including G-CSF, GM-CSF , EPO, and TPO, etc.) within 14 days prior to screening):
- Hemoglobin ≥ 90 g/L;
- White blood cell count ≥ lower limit of laboratory normal;
- Absolute neutrophil count (ANC) ≥ 1.5 × 109/L;
- Platelet count ≥100×109/L;
- Total bilirubin ≤ 1.5 x upper limit of normal (ULN);
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN;
- Prothrombin time ≤ 16 seconds and International Normalized Ratio (INR) ≤ 1.5 x ULN;
- Creatinine ≤ 1.5 x ULN and Cr clearance ≥ 50 mL/min (calculated using the Cockcroft-Gault formula);
- Must understand and voluntarily sign an informed consent form.
Who cannot join
- malignant tumors other than esophageal cancer within 5 years prior to enrollment (cured limited tumors are not excluded, including cervical carcinoma in situ, basal cell carcinoma of the skin, and carcinoma in situ of the prostate gland; patients with prostate cancer who received hormone therapy and obtained DFS for more than 5 years are not excluded)；
- Comorbid serious cardiac and cerebrovascular diseases:
- Congestive heart failure, unstable angina, myocardial infarction, poorly controlled arrhythmia, or cerebrovascular accident of New York Heart Association (NYHA) class II or higher within 12 months prior to enrollment.
- Medication-uncontrolled hypertension (systolic blood pressure ≥150 mmHg and/or diastolic blood pressure ≥100 mmHg) (based on the average of ≥2 measurements)
- Previous hypertensive crisis or hypertensive encephalopathy
- Prior history of interstitial lung disease or pneumonia requiring steroid therapy at enrollment；
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- Have a blood-borne infectious disease, including, but not limited to, hepatitis B virus carrier, hepatitis C, syphilis, or HIV;
- Previous severe allergy to chemotherapeutic agents (paclitaxel or carboplatin) or to any of the monoclonal antibodies;
- Active autoimmune disease requiring systemic therapy (i.e., immunomodulatory drugs, corticosteroid drugs, or immunosuppressive drugs) within the past 2 years; however, alternative therapies (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) are not considered systemic and are permitted and enrollment is allowed;
- Women during pregnancy;
- Patients who, in the opinion of the investigator, are not suitable for participation in this study, based on a comprehensive assessment.
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
Peking University Cancer Hospital
Beijing, 100142
Luyan Shen, 15811408473, shenluyan@pku.edu.cn
About this study
This study is a prospective, observational clinical study. In this study, 30 patients with resectable locally advanced esophageal squamous carcinoma will be prospectively enrolled and treated with adebrelimab (SHR-1316) combined with nab-paclitaxel and cisplatin preoperatively and adebrelimab (SHR-1316) single-agent adjuvant therapy postoperatively, to observe the efficacy and safety of this treatment modality, and to provide clinical evidence for the use of PD-L1 monoclonal antibody in perioperative treatment of esophageal cancer.
- Conditions
- Esophageal Cancer (EsC)
- Being tested
- Adebrelimab (SHR-1316) + Nab-paclitaxel + Cisplatin
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adebrelimab (SHR-1316) + Nab-paclitaxel + CisplatinDrug
All subjects were given 3 cycles of neoadjuvant therapy with adebrelimab (1200 mg D1, IV, Q3W)+Nab-paclitaxel(250 mg/m2 D1，IV，Q3W)+Cisplatin(75 mg/m2 D1，IV，Q3W) preoperatively. Within 4-8 weeks of completion of neoadjuvant therapy, all subjects who were suitable for surgery underwent radical surgery, and patients who underwent radical esophageal cancer with R0 resection were given adebrelimab monotherapy postoperatively until disease recurrence or metastasis, toxicity intolerance, initiation of a new antitumor therapy, subject-initiated request to withdraw from the study, and subject's judgement that the subject needed to be withdrawn from the study. The maximum duration of adebrelimab in the adjuvant phase is 16 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Adebrelimab (SHR-1316)+chemotherapy | Experimental | Not described Receives: Drug: Adebrelimab (SHR-1316) + Nab-paclitaxel + Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic complete response rate (pCR)
The rate of pathologic complete response rate after neoadjuvant therapy
Measured: Three weeks after surgery of last enrolled subject. Estimate up to 2 years
Adverse Events (AE)
Incidence and grade (including serious adverse events and immunization-related adverse events), as determined by NCI-CTCAE 5.0 criteria
Measured: about 2 years
Secondary outcomes (7)
R0 resection rate
The R0 resection rate of esophagectomy
Measured: Three weeks after surgery of last enrolled subject. Estimate up to 2 years
Major pathologic response rate
The percentage of subjects with ≤10% survival tumor cells in the resected specimens after neoadjuvant therapy accounted for all subjects who received surgical treatment.
Measured: Three weeks after surgery of last enrolled subject. Estimate up to 2 years.
Objective Response Rate
The percentage of patients having a complete response or a partial response to protocol treatment. Objective response will be measured by RECIST 1.1.
Measured: Estimate up to 2 years
Event-free survival (EFS)
The length of time between signing the informed consent form and the occurrence of any of the following events: disease progression, disease recurrence, or death from any cause
Measured: Estimate up to 2 years
1-year event-free survival rate (1-year EFS)
The percentage of subjects who were free of the occurrence of any of the events(disease progression, disease recurrence, or death from any cause) from the start of study enrolment to 12 months later.
Measured: Estimate up to 2 years
Disease-free survival (DFS)
The time from enrolment (ICF signing) to disease recurrence or death due to disease progression.
Measured: about 2 years
1-year disease-free survival rate (1-year DFS)
The percentage of subjects who were free of disease recurrence or death from the start of study enrolment to 12 months later.
Measured: about 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start31 Mar 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Cancer (EsC)Studies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06869213
- Sponsor's protocol ID
- 2024KT157
- Status last verified
- Mar 2025
- First submitted
- 5 Mar 2025
- Last updated
- 2 Oct 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Open, Single-center Exploratory Study of Adebrelimab (SHR-1316) in Combination With Chemotherapy for the Perioperative Treatment of Locally Advanced Resectable Esophageal Squamous Carcinoma
- ClinicalTrials.gov ID
- NCT06869213
- Acronym / sponsor ID
- 2024KT157
- Conditions
- Esophageal Cancer (EsC)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 31 Mar 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 11 Mar 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.
This study is a prospective, observational clinical study. In this study, 30 patients with resectable locally advanced esophageal squamous carcinoma will be prospectively enrolled and treated with adebrelimab (SHR-1316) combined with nab-paclitaxel and cisplatin preoperatively and adebrelimab (SHR-1316) single-agent adjuvant therapy postoperatively, to observe the efficacy and safety of this treatment modality, and to provide clinical evidence for the use of PD-L1 monoclonal antibody in perioperative treatment of esophageal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adebrelimab (SHR-1316)+chemotherapy | Experimental | Drug: Adebrelimab (SHR-1316) + Nab-paclitaxel + Cisplatin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Aged 18-75 years old, regardless of gender；
- Surgically resectable locally advanced squamous cell carcinoma of the esophagus confirmed by histology or cytology (pre-treatment clinical stage cT1b-cT2, N+ or cT3-cT4a, ANY N according to the 8th edition of AJCC staging);
- Presence of measurable and/or non-measurable lesions as defined by the criteria for evaluating the efficacy of solid tumors (RECIST v1.1);
- No prior antitumor therapy for esophageal cancer, including chemotherapy, radiotherapy (including planned radiotherapy during the study period), hormone therapy, and immunotherapy;
- ECOG PS 0 to 1 point;
Key exclusion criteria (11 listed)
- malignant tumors other than esophageal cancer within 5 years prior to enrollment (cured limited tumors are not excluded, including cervical carcinoma in situ, basal cell carcinoma of the skin, and carcinoma in situ of the prostate gland; patients with prostate cancer who received hormone therapy and obtained DFS for more than 5 years are not excluded)；
- Comorbid serious cardiac and cerebrovascular diseases:
- Prior history of interstitial lung disease or pneumonia requiring steroid therapy at enrollment；
- Have a blood-borne infectious disease, including, but not limited to, hepatitis B virus carrier, hepatitis C, syphilis, or HIV;
- Previous severe allergy to chemotherapeutic agents (paclitaxel or carboplatin) or to any of the monoclonal antibodies;
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 (SHR-1316) + Nab-paclitaxel + CisplatinAll subjects were given 3 cycles of neoadjuvant therapy with adebrelimab (1200 mg D1, IV, Q3W)+Nab-paclitaxel(250 mg/m2 D1，IV，Q3W)+Cisplatin(75 mg/m2 D1，IV，Q3W) preoperatively. Within 4-8 weeks of completion of neoadjuvant therapy, all subjects who were suitable for surgery underwent radical surgery, and patients who underwent radical esophageal cancer with R0 resection were given adebrelimab monotherapy postoperatively until disease recurrence or metastasis, toxicity intolerance, initiation of a new antitumor therapy, subject-initiated request to withdraw from the study, and subject's judgement that the subject needed to be withdrawn from the study. The maximum duration of adebrelimab in the adjuvant phase is 16 cycles. | Drug | Adebrelimab (SHR-1316)+chemotherapy |
Primary outcome
Pathologic complete response rate (pCR)
Time frame: Three weeks after surgery of last enrolled subject. Estimate up to 2 years
The rate of pathologic complete response rate after neoadjuvant therapy
Adverse Events (AE)
Time frame: about 2 years
Incidence and grade (including serious adverse events and immunization-related adverse events), as determined by NCI-CTCAE 5.0 criteria
7 secondary outcomes
R0 resection rate
Time frame: Three weeks after surgery of last enrolled subject. Estimate up to 2 years
Major pathologic response rate
Time frame: Three weeks after surgery of last enrolled subject. Estimate up to 2 years.
Objective Response Rate
Time frame: Estimate up to 2 years
Event-free survival (EFS)
Time frame: Estimate up to 2 years
1-year event-free survival rate (1-year EFS)
Time frame: Estimate up to 2 years
Disease-free survival (DFS)
Time frame: about 2 years
1-year disease-free survival rate (1-year DFS)
Time frame: about 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 2 Oct 2025.
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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.
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 (SHR-1316) + Nab-paclitaxel + Cisplatin in people with Esophageal Cancer (EsC), run by Peking University Cancer Hospital & Institute 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 16 inclusion and 11 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 2 Oct 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathologic complete response rate (pCR) (time frame: Three weeks after surgery of last enrolled subject. Estimate up to 2 years). The study lists 2 primary outcomes in all. 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 2 Oct 2025.