Esophageal Squamous Cell CarcinomaPhase 2NCT06178211
Neoadjuvant Adebrelimab Plus Chemotherapy for Resectable ESCC: a Single Arm, Prospective Phase 2 Clinical Trial
A Phase 2 study testing Immunotherapy: Adebrelimab and chemotherapy: carboplatin plus nab-paclitaxel in people with Esophageal Squamous Cell Carcinoma, run by Shanghai Chest Hospital at 1 site in China.
Trial summary
The investigators will conduct a single-arm prospective study to evaluate the efficacy and safety of neoadjuvant therapy with adebrelimab (SHR-1316) and chemotherapy in patients with resectable esophageal squamous cell carcinoma (ESCC). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma
- What is being tested?
- Immunotherapy: Adebrelimab and chemotherapy: carboplatin plus nab-paclitaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- Dec 2023to Nov 2026
- 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
- Subjects signed the informed consent and volunteered to participate in the study.
- Esophageal squamous cell carcinoma confirmed by histology or cytology.
- Thoracic esophageal squamous cell carcinoma confirmed by CT or pet-CT, which is classified as cII-III (AJCC 8th).
- Expect to have R0 resection
- In age from 18 to 75.
- ECOG PS: 0~1.
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- Have not received any anti-tumor treatment for esophageal cancer in the past, including radiotherapy, chemotherapy, surgery, etc.
- No contraindications to surgery.
- Has sufficient organ function including (1) Blood routine: NE≥1.5×109/L; PLT≥100×109/L; HGB≥90 g/L (2)Comprehensive Metabolic Panel: bilirubin≤ 1.5×ULN; ALT≤2.5×ULN; AST≤2.5×ULN; sCr≤1.5×ULN or CrCl≥50 mL/min（Cocheroft-Gault) (3) Coagulation function: INR≤1.5; APTT≤1.5×ULN
- Women of childbearing age must undergo a serological pregnancy test within 72 hrs before first administration. Women of childbearing age, or male subjects with childbearing age female partners, must take contraceptive measures from the first dose to three months after last administration.
- Good compliance, willing to comply with follow-up schedules.
Who cannot join
- Subjects have received or are receiving any of:
- anti-tumor interventions such as radiotherapy, chemotherapy or other medictions.
- immunosuppresants or systemic glucosteroids (prednisone equivalence> 10mg/d) within 2 weeks before the first administration, inhaled or topical use of glucosteroids (prednisone equivalence>10mg/d) is allowed if no known active autoimmune disease.
- live vaccine within 4 weeks before the first administration.
- major surgery or major injury within 4 weeks before the first administration.
- Cancer related exclusion criteria
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- other cancers instead of ESCC
- non-recetable or metastatic ESCC
- not comply with cⅡ-Ⅲ（cT2N1-2M0 or cT3N0-2M0, AJCC 8th）
- Subjects with other malignant tumors within 5 years before the first administration, but subjects with cervical carcinoma in situ, skin basal cell carcinoma, skin squamous cell carcinoma, localized prostate cancer received radical surgery and ductal carcinoma in situ that have received radical treatment and do not need other treatment can be included)
- Other criteria
- Subjects have uncontrolled cardiovascular diseases, such as 1) heart failure ≥ NYHA class 2, 2) unstable angina 3) myocardial infarction within 1 year; 4) supraventricular or ventricular arrthymia that needs treatment
- Subjects with any known active autoimmune disease
- Pregnant or breastfeeding female
- Presence of allergy or hypersensitivity to investigational medications
- HIV positive or active hepatitis B (HbsAg positive and HBV-DNA ≥2000 IU/ml or ≥ 104 copies/mL) or active hepatitis C (HCV antibody positive) or active tuberculosis
- Investigators assessed there might be other factors that cause subjects to withdrawl.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The investigators will conduct a single-arm prospective study to evaluate the efficacy and safety of neoadjuvant therapy with adebrelimab (SHR-1316) and chemotherapy in patients with resectable esophageal squamous cell carcinoma (ESCC).
- Conditions
- Esophageal Squamous Cell Carcinoma
- Being tested
- Immunotherapy: Adebrelimab, chemotherapy: carboplatin plus nab-paclitaxel
- Medical subject headings
- Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunotherapy: AdebrelimabDrug
Adebrelimab 1200mg Q3W
chemotherapy: carboplatin plus nab-paclitaxelDrug
carboplatin plus nab-paclitaxel
| Study group | Role | What they receive |
|---|---|---|
| adebrelimab and chemotherapy | Experimental | Not described Receives: Drug: Immunotherapy: Adebrelimab; Drug: chemotherapy: carboplatin plus nab-paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
pCR rate
The primary endpoint is a pCR rate, which is defined as the absence of any remaining tumor cells in both the main tumor and the nearby lymph nodes (ypT0N0) as per the AJCC 8th Edition TRG scoring system.
Measured: 12 months
Secondary outcomes (7)
cCR rate
A clinical complete response rate (cCR) is defined as the complete disappearance of tumor lesions as assessed by enhanced CT, endoscopic ultrasound, and endoscopic biopsy.
Measured: 12 months
R0 resection rate
A R0 resection rate is defined as the rate of complete tumor removal with negative resection margin microscopically
Measured: 12 months
MPR rate
A major pathological response rate (MPR) is defined as the proportion of residual living tumor cells in the post-surgery specimen within the tumor bed being less than or equal to 10%.
Measured: 12 months
median EFS
An event-free survival (EFS) is defined as the duration from the start of treatment until disease recurrence or death from any cause, whichever occurs first.
Measured: 12 months
median OS
An overall survival (OS) is defined as the time from treatment to death, regardless of disease recurrence.
Measured: 12 months
Incidence, type and severity of adverse events as assessed by CTCAE 5.0
Including adverse events and complications. Incidence of adverse events using CTCAE 5.0; grade 3 treatment-related adverse events and higher-grade will be reported
Measured: From date of treatment allocation until surgery was applied during study period or up to at least 90 days after last dose
Potential biomarkers such as ctDNA or PD-L1 expression
Potential biomarkers such as ctDNA or PD-L1 expression will be explored and analysed using blood or tissues prior and post-treatment.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2023
- Study startDec 2023 (estimated)
- Primary completionMar 2025 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Squamous Cell CarcinomaStudies 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
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Chest Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhigang Li, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06178211
- Sponsor's protocol ID
- MA-EC-II-015
- Status last verified
- Dec 2023
- First submitted
- 18 Nov 2023
- Last updated
- 20 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Adebrelimab Plus Chemotherapy for Resectable ESCC: a Single Arm, Prospective Phase 2 Clinical Trial
- ClinicalTrials.gov ID
- NCT06178211
- Acronym / sponsor ID
- MA-EC-II-015
- Conditions
- Esophageal Squamous Cell Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Study start
- Dec 2023 (estimated)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 20 Dec 2023 (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.
The investigators will conduct a single-arm prospective study to evaluate the efficacy and safety of neoadjuvant therapy with adebrelimab (SHR-1316) and chemotherapy in patients with resectable esophageal squamous cell carcinoma (ESCC).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| adebrelimab and chemotherapy | Experimental | Drug: Immunotherapy: Adebrelimab, Drug: chemotherapy: carboplatin plus nab-paclitaxel |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subjects signed the informed consent and volunteered to participate in the study.
- Esophageal squamous cell carcinoma confirmed by histology or cytology.
- Thoracic esophageal squamous cell carcinoma confirmed by CT or pet-CT, which is classified as cII-III (AJCC 8th).
- Expect to have R0 resection
- In age from 18 to 75.
Key exclusion criteria (17 listed)
- Subjects have received or are receiving any of:
- Cancer related exclusion criteria
- Other criteria
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 |
|---|---|---|
| Immunotherapy: AdebrelimabAdebrelimab 1200mg Q3W | Drug | adebrelimab and chemotherapy |
| chemotherapy: carboplatin plus nab-paclitaxelcarboplatin plus nab-paclitaxel | Drug | adebrelimab and chemotherapy |
Primary outcome
pCR rate
Time frame: 12 months
The primary endpoint is a pCR rate, which is defined as the absence of any remaining tumor cells in both the main tumor and the nearby lymph nodes (ypT0N0) as per the AJCC 8th Edition TRG scoring system.
7 secondary outcomes
cCR rate
Time frame: 12 months
R0 resection rate
Time frame: 12 months
MPR rate
Time frame: 12 months
median EFS
Time frame: 12 months
median OS
Time frame: 12 months
Incidence, type and severity of adverse events as assessed by CTCAE 5.0
Time frame: From date of treatment allocation until surgery was applied during study period or up to at least 90 days after last dose
Potential biomarkers such as ctDNA or PD-L1 expression
Time frame: 12 months
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 20 Dec 2023.
- Individual participant dataSharing planned: Undecided
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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 Immunotherapy: Adebrelimab and chemotherapy: carboplatin plus nab-paclitaxel in people with Esophageal Squamous Cell Carcinoma, run by Shanghai Chest 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 11 inclusion and 17 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 20 Dec 2023. 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 Zhigang Li, MD, PhD (18960619260, dr_lizhigang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pCR rate (time frame: 12 months). 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 20 Dec 2023.