Esophageal Squamous Cell CarcinomaPhase 1/2NCT07385001
A Prospective, Multicenter, Phase Ib/II Trial of Ivonescimab (AK112) Combined With Albumin-Paclitaxel and Cisplatin as Neoadjuvant Therapy for ESCC
A Phase 1/2 study testing AK112 and AK112 + Neoadjuvant chemotherapy in people with Esophageal Squamous Cell Carcinoma and Ivonescimab, run by Tang-Du Hospital at 1 site in China.
Trial summary
A Prospective, Multicenter, Phase Ib/II Trial of Ivonescimab (AK112) Combined with Albumin-Paclitaxel and Cisplatin as Neoadjuvant Therapy for Resectable, Locally Advanced Esophageal Squamous Cell Carcinoma Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma, Ivonescimab, Neoadjuvant
- What is being tested?
- AK112 and AK112 + Neoadjuvant chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- 28 Jan 2026to 28 Jan 2028
- Phase
- Phase 1/2
- 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
- Informed Consent: Written informed consent must be obtained before any study-related procedures are initiated.
- Age and Gender: Participants must be between 18 and 75 years of age, inclusive of both 18 and 75 years, and may be either male or female.
- Diagnosis and Stage: Participants must be histologically confirmed to have resectable, locally advanced esophageal squamous cell carcinoma (ESCC) with the following criteria:-T1 N1-N3 M0 or T2-T4a N0-N3 M0 (with T2 ≥ 2 cm or poorly differentiated).
- Lymph Node Status: No suspicious lymph nodes in the neck region (excluding lymph nodes in the upper thoracic esophageal area) as per neck ultrasound or enhanced CT scan; no evidence of systemic metastasis on imaging.
- R0 Resectability: The participant is expected to achieve R0 resection.
- Measurable Lesion: At least one measurable tumor lesion must be present.
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- Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Expected Survival: The participant is expected to have a survival duration of at least 3 months.
- Thyroid Function: Normal thyroid function is defined as a thyroid-stimulating hormone (TSH) level within the normal range. Participants with baseline TSH levels outside the normal range may still be eligible if total T3 (or free T3) and free T4 levels are within the normal range.
- Organ Function: Laboratory results must meet the following criteria:
- Hematology (no blood transfusion or blood component or granulocyte colony-stimulating factor treatment within 14 days): Neutrophil count (NEU) ≥ 1.5 × 10⁹/L (1,500/mm³); Platelet count (PLT) ≥ 100 × 10⁹/L (100,000/mm³); Hemoglobin ≥ 90 g/L.
- Liver: Total bilirubin (TBil) ≤ 1.5 × upper limit of normal (ULN); or for participants with TBil < 1.5 × ULN, direct bilirubin must be within the normal range; Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 2.5 × ULN.
- Renal: Serum creatinine ≤ 1.5 × ULN or calculated creatinine clearance (CrCl) ≥ 60 mL/min (using the Cockcroft-Gault formula).
- Coagulation: International Normalized Ratio (INR) ≤ 1.5; Prothrombin time (PT) or Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN.
- Cardiac Function: Left ventricular ejection fraction (LVEF) ≥ 50%.
- Pregnancy Testing and Contraception: For screening-period eligible female participants of reproductive age, a serum pregnancy test must be negative. Female or male participants of reproductive capacity must be willing to use a reliable contraceptive method throughout the study period (i.e., from the date of informed consent to 90 days after the last dose of study drug), including but not limited to: abstinence, vasectomy in the male partner, sterilization in the female, effective intrauterine devices, and effective oral contraceptives.
- Compliance: The participant must be willing and able to comply with the study schedule, including visits, treatment regimen, laboratory tests, and other study requirements.
Who cannot join
- History of Other Malignancies: Participants who have had any other malignancy within 5 years prior to enrollment are excluded, except for those with localized or in situ malignancies such as basal or squamous cell carcinoma, superficial bladder cancer, cervical or breast intraepithelial neoplasia, or other conditions that are considered curable with local therapy.
- Prior Treatment with PD-1/PD-L1 Inhibitors or Other Immune-Modulating Drugs: Participants who have previously received treatment with PD-1/PD-L1 inhibitors or other drugs targeting T-cell receptors (e.g., CTLA-4, OX-40) or anti-angiogenic agents (e.g., bevacizumab, endostar) are excluded.
- Systemic Non-Specific Immune Modulation: Participants who have received systemic non-specific immune-modulating therapy (e.g., interleukins, interferons, thymopentin) within 2 weeks prior to the first dose of study drug, or who have used traditional Chinese medicine or herbal preparations with anti-tumor indications within 2 weeks prior to the first dose, are excluded.
- Active Autoimmune Disease Requiring Systemic Treatment: Participants with active autoimmune diseases requiring systemic treatment (e.g., using disease-modifying antirheumatic drugs, corticosteroids, or immunosuppressants) are excluded. Substitutive treatments (e.g., thyroid hormone, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) are not considered as systemic treatment.
- Brainstem, Meningeal, or Spinal Metastasis or Compression: Participants with brainstem, meningeal, or spinal metastasis, or with evidence of compression, are excluded.
- Significant Pleural, Pericardial, or Peritoneal Effusion: Participants with clinically significant pleural, pericardial, or peritoneal effusions requiring diuretic therapy and/or repeated drainage are excluded.
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- Gastrointestinal Obstruction or Complications Within 6 Months of First Dose: Participants with a history of clinically significant gastrointestinal obstruction, perforation, intra-abdominal abscess, or fistula formation within 6 months prior to the first dose of study drug are excluded.
- Active Inflammatory Gastrointestinal Diseases: Participants with active inflammatory gastrointestinal diseases (e.g., Crohn's disease, ulcerative colitis, radiation enteritis, hemorrhagic enteritis, chronic diarrhea) are excluded.
- Tumor Encircling Major Vessels or Severe Necrosis/Hemorrhage: Participants with imaging findings showing tumor encircling major vessels, significant necrosis, or cavitation, and whose researchers determine that entry into the study would pose a bleeding risk, are excluded.
- Interstitial Lung Disease ≥ Grade 2: Participants with interstitial lung disease ≥ Grade 2 are excluded.
- Severe Cardiovascular Disease:
- Uncontrolled hypertension or pulmonary hypertension; Unstable angina pectoris, myocardial infarction within 6 months prior to the first dose of study drug, coronary artery bypass grafting, or stent implantation; Chronic heart failure with NYHA functional class ≥ 2; Left ventricular ejection fraction (LVEF) < 50%;
- Severe arrhythmias requiring drug treatment (excluding atrial fibrillation or paroxysmal supraventricular tachycardia), such as QTcF > 450 msec in males or > 470 msec in females, complete left bundle branch block, or third-degree heart block; Cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 4 weeks prior to the first dose of study drug.
- Severe Infection Within 4 Weeks Prior to First Dose: Participants with a history of severe infection (e.g., sepsis, bacteremia, or severe pneumonia) within 4 weeks prior to the first dose of study drug, or who have received systemic antimicrobial therapy for an active infection (excluding antiviral treatment for hepatitis B or C) within 2 weeks prior to the first dose, are excluded.
- Active Tuberculosis or Syphilis: Participants with known active tuberculosis (TB) or syphilis are excluded. Suspected TB cases must be ruled out with clinical evaluation.
- Positive HIV Antibody or Active Hepatitis B or C:
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 Hospitial
Xi'an, Shannxi
Xing Li, +86 02984777551, tangduec@126.com
Xiaolong Yan
About this study
Official title: Phase Ib/II Trial of Atezolizumab (AK112) Combined With Albumin-Paclitaxel and Cisplatin as Neoadjuvant Therapy for Resectable, Locally Advanced Esophageal Squamous Cell Carcinoma
A Prospective, Multicenter, Phase Ib/II Trial of Ivonescimab (AK112) Combined with Albumin-Paclitaxel and Cisplatin as Neoadjuvant Therapy for Resectable, Locally Advanced Esophageal Squamous Cell Carcinoma
- Conditions
- Esophageal Squamous Cell Carcinoma, Ivonescimab, Neoadjuvant
- Being tested
- AK112, AK112 + Neoadjuvant chemotherapy
- Keywords
- Neoadjuvant, Esophageal Squamous Cell Carcinoma
- 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.
AK112Drug
Cohort 1- AK112 10 mg/kg, every 3 weeks (Q3W), administered intravenously on day 1. Treatment will begin with the first patient. If the first patient does not experience any treatment-related safety issues, at least 24 hours will pass before the next 2 or 3 patients are treated.The dosing regimen and interval will remain unchanged for all patients
AK112Drug
Cohort 2- AK112 dose of 20 mg/kg, every 3 weeks (Q3W), administered intravenously on day 1. Treatment will begin with the first patient. If the first patient does not experience any treatment-related safety issues, at least 24 hours will pass before the next 2 or 3 patients are treated.The dosing regimen and interval will remain unchanged for all patients
AK112 + Neoadjuvant chemotherapyDrug
Neoadjuvant chemotherapy:
Albumin-paclitaxel 130 mg/m², intravenous infusion on days 1 and 8, every 3 weeks (Q3W), total of 3 cycles Carboplatin with an area under the curve (AUC) of 5 mg/ml/min, intravenous infusion on day 1, every 3 weeks (Q3W), total of 3 cycles
AK112:
Based on the data collected during the dose-escalation phase 1b
| Study group | Role | What they receive |
|---|---|---|
| Phase 1b-Cohort 1 | Experimental | Subjects will receive AK112 via intravenously (IV) Q3W Receives: Drug: AK112 |
| Phase 1b-Cohort 2 | Experimental | Subjects will receive AK112 via intravenously (IV) Q3W Receives: Drug: AK112 |
| Phase 2a | Experimental | Subjects will receive AK112 via intravenously (IV) Q3W+Albumin-paclitaxel 130 mg/m²,via intravenously (IV); carboplatin with an area under the curve (AUC) of 5 mg/ml/min, via intravenously (IV) Q3W, for a total of 3 cycles Receives: Drug: AK112 + Neoadjuvant chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLT
Dose-limiting toxicity
Measured: 1 year
Incidence and Severity of Adverse Events
Measured: 1 year
MTD
Maximum tolerated dose
Measured: 1 year
RP2D
Recommended Phase II Dose
Measured: 1 year
Major Pathologic Response(MPR)
Defined as a residual viable tumor percentage (RVT%) ≤ 10%
Measured: up to 2 years
Secondary outcomes (4)
Objective response rate (ORR) by RECIST v1.1
ORR is defined as the proportion of subjects with confirmed CR or confirmed PR
Measured: Up to 2 years
Event-Free Survival (EFS)
EFS is defined as the time from randomization to the occurrence of any event, including disease progression, treatment discontinuation for any reason, or death.
Measured: Up to 2 years
Total survival time (OS)
OS defined as the time from the first dose to death from any cause
Measured: Up to 2 years
Adverse Events (AE), Serious Adverse Events (SAE), and Immune-Related Adverse Events (irAE): Incidence and Severity
Measured: From the time of informed consent signed through 90 days after the last dose of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start28 Jan 2026 (estimated)
- Primary completion28 Jan 2027 (estimated)
- Study completion28 Jan 2028 (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.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07385001
- Sponsor's protocol ID
- K202506-23
- Status last verified
- Jan 2026
- First submitted
- 8 Jul 2025
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ib/II Trial of Atezolizumab (AK112) Combined With Albumin-Paclitaxel and Cisplatin as Neoadjuvant Therapy for Resectable, Locally Advanced Esophageal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT07385001
- Acronym / sponsor ID
- K202506-23
- Conditions
- Esophageal Squamous Cell Carcinoma, Ivonescimab, Neoadjuvant
- Keywords
- Neoadjuvant, Esophageal Squamous Cell Carcinoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Study start
- 28 Jan 2026 (estimated)
- Primary completion
- 28 Jan 2027 (estimated)
- Study completion
- 28 Jan 2028 (estimated)
- First posted
- 3 Feb 2026 (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.
A Prospective, Multicenter, Phase Ib/II Trial of Ivonescimab (AK112) Combined with Albumin-Paclitaxel and Cisplatin as Neoadjuvant Therapy for Resectable, Locally Advanced Esophageal Squamous Cell Carcinoma
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase 1b-Cohort 1 | Experimental | Drug: AK112Subjects will receive AK112 via intravenously (IV) Q3W |
| Phase 1b-Cohort 2 | Experimental | Drug: AK112Subjects will receive AK112 via intravenously (IV) Q3W |
| Phase 2a | Experimental | Drug: AK112 + Neoadjuvant chemotherapySubjects will receive AK112 via intravenously (IV) Q3W+Albumin-paclitaxel 130 mg/m²,via intravenously (IV); carboplatin with an area under the curve (AUC) of 5 mg/ml/min, via intravenously (IV) Q3W, for a total of 3 cycles |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Informed Consent: Written informed consent must be obtained before any study-related procedures are initiated.
- Age and Gender: Participants must be between 18 and 75 years of age, inclusive of both 18 and 75 years, and may be either male or female.
- Diagnosis and Stage: Participants must be histologically confirmed to have resectable, locally advanced esophageal squamous cell carcinoma (ESCC) with the following criteria:-T1 N1-N3 M0 or T2-T4a N0-N3 M0 (with T2 ≥ 2 cm or poorly differentiated).
- Lymph Node Status: No suspicious lymph nodes in the neck region (excluding lymph nodes in the upper thoracic esophageal area) as per neck ultrasound or enhanced CT scan; no evidence of systemic metastasis on imaging.
- R0 Resectability: The participant is expected to achieve R0 resection.
Key exclusion criteria (16 listed)
- History of Other Malignancies: Participants who have had any other malignancy within 5 years prior to enrollment are excluded, except for those with localized or in situ malignancies such as basal or squamous cell carcinoma, superficial bladder cancer, cervical or breast intraepithelial neoplasia, or other conditions that are considered curable with local therapy.
- Prior Treatment with PD-1/PD-L1 Inhibitors or Other Immune-Modulating Drugs: Participants who have previously received treatment with PD-1/PD-L1 inhibitors or other drugs targeting T-cell receptors (e.g., CTLA-4, OX-40) or anti-angiogenic agents (e.g., bevacizumab, endostar) are excluded.
- Systemic Non-Specific Immune Modulation: Participants who have received systemic non-specific immune-modulating therapy (e.g., interleukins, interferons, thymopentin) within 2 weeks prior to the first dose of study drug, or who have used traditional Chinese medicine or herbal preparations with anti-tumor indications within 2 weeks prior to the first dose, are excluded.
- Active Autoimmune Disease Requiring Systemic Treatment: Participants with active autoimmune diseases requiring systemic treatment (e.g., using disease-modifying antirheumatic drugs, corticosteroids, or immunosuppressants) are excluded. Substitutive treatments (e.g., thyroid hormone, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) are not considered as systemic treatment.
- Brainstem, Meningeal, or Spinal Metastasis or Compression: Participants with brainstem, meningeal, or spinal metastasis, or with evidence of compression, are excluded.
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 |
|---|---|---|
| AK112Cohort 1- AK112 10 mg/kg, every 3 weeks (Q3W), administered intravenously on day 1. Treatment will begin with the first patient. If the first patient does not experience any treatment-related safety issues, at least 24 hours will pass before the next 2 or 3 patients are treated.The dosing regimen and interval will remain unchanged for all patients | Drug | Phase 1b-Cohort 1 |
| AK112Cohort 2- AK112 dose of 20 mg/kg, every 3 weeks (Q3W), administered intravenously on day 1. Treatment will begin with the first patient. If the first patient does not experience any treatment-related safety issues, at least 24 hours will pass before the next 2 or 3 patients are treated.The dosing regimen and interval will remain unchanged for all patients | Drug | Phase 1b-Cohort 2 |
| AK112 + Neoadjuvant chemotherapyNeoadjuvant chemotherapy: Albumin-paclitaxel 130 mg/m², intravenous infusion on days 1 and 8, every 3 weeks (Q3W), total of 3 cycles Carboplatin with an area under the curve (AUC) of 5 mg/ml/min, intravenous infusion on day 1, every 3 weeks (Q3W), total of 3 cycles AK112: Based on the data collected during the dose-escalation phase 1b | Drug | Phase 2a |
Primary outcome
DLT
Time frame: 1 year
Dose-limiting toxicity
Incidence and Severity of Adverse Events
Time frame: 1 year
MTD
Time frame: 1 year
Maximum tolerated dose
RP2D
Time frame: 1 year
Recommended Phase II Dose
Major Pathologic Response(MPR)
Time frame: up to 2 years
Defined as a residual viable tumor percentage (RVT%) ≤ 10%
4 secondary outcomes
Objective response rate (ORR) by RECIST v1.1
Time frame: Up to 2 years
Event-Free Survival (EFS)
Time frame: Up to 2 years
Total survival time (OS)
Time frame: Up to 2 years
Adverse Events (AE), Serious Adverse Events (SAE), and Immune-Related Adverse Events (irAE): Incidence and Severity
Time frame: From the time of informed consent signed through 90 days after the last dose of study drug
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 3 Feb 2026.
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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 1/2 study testing AK112 and AK112 + Neoadjuvant chemotherapy in people with Esophageal Squamous Cell Carcinoma and Ivonescimab, 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 17 inclusion and 16 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 3 Feb 2026. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Xiaolong Yan (+86 15991269383, yanxiaolong@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DLT (time frame: 1 year). The study lists 5 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 3 Feb 2026.