Esophageal Squamous Cell CarcinomaPhase 2NCT07830355
Immunotherapy Plus Anlotinib After Surgery for Esophageal Squamous Cell Cancer With Residual Tumor and Positive Lymph Nodes
A Phase 2 study testing Anlotinib and Anti-PD-1 Monoclonal Antibody in people with Esophageal Squamous Cell Carcinoma, run by Shanghai Chest Hospital.
Trial summary
The goal of this clinical trial is to learn whether postoperative immunotherapy combined with anlotinib can help prevent or delay cancer recurrence in adults aged 18 to 75 years with 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
- What is being tested?
- Anlotinib and Anti-PD-1 Monoclonal Antibody
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Dec 2029
- 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
- Age 18 to 75 years, inclusive.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Histologically confirmed locally advanced esophageal squamous cell carcinoma.
- Prior treatment with 2 to 4 cycles of neoadjuvant chemotherapy combined with an anti-PD-1 monoclonal antibody, followed by radical surgery with pathologically confirmed R0 resection.
- An interval of no more than 10 weeks between completion of the last neoadjuvant chemotherapy or immunotherapy treatment and radical surgery.
- Postoperative pathological assessment showing non-major pathological response, defined as more than 10% residual viable tumor cells in the primary tumor bed, and viable tumor metastasis in at least one resected regional lymph node (ypN-positive disease).
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- Enrollment within 10 weeks after esophagectomy.
- Ability to swallow and tolerate oral medication, without severe dysphagia, chronic diarrhea, intestinal obstruction, or another condition that may substantially affect oral drug absorption.
- Adequate organ function, based on laboratory tests performed within 7 days before the first dose and without blood transfusion, erythropoietin, granulocyte colony-stimulating factor, or similar supportive treatment within the preceding 14 days, meeting all of the following criteria:
- Absolute neutrophil count ≥1.5 × 10^9/L.
- Platelet count ≥100 × 10^9/L.
- Hemoglobin ≥90 g/L.
- Total bilirubin ≤1.5 × the upper limit of normal (ULN).
- Alanine aminotransferase and aspartate aminotransferase ≤2.5 × ULN.
- Serum creatinine ≤1.5 × ULN or creatinine clearance ≥60 mL/min.
- Urine protein negative or 1+ on routine urinalysis. If urine protein is 2+ or higher, 24-hour urinary protein must be ≤1.0 g.
- International normalized ratio ≤1.5, prothrombin time no more than 4 seconds above ULN, and activated partial thromboplastin time ≤1.5 × ULN.
- Systolic blood pressure <140 mmHg and diastolic blood pressure <90 mmHg, without antihypertensive medication or while receiving no more than two antihypertensive medications.
- Thyroid-stimulating hormone within the normal range. Participants with abnormal thyroid-stimulating hormone may be eligible if free triiodothyronine and free thyroxine are within the normal ranges and the investigator determines that systemic immunosuppressive treatment is not required and that observation, stable endocrine replacement therapy, or symptomatic treatment is sufficient.
- Fasting blood glucose ≤10 mmol/L or glycated hemoglobin ≤8%. Participants with diabetes must have stable glycemic control with medication.
- Left ventricular ejection fraction ≥50% and resting corrected QT interval <480 milliseconds.
- No myocardial infarction or severe or unstable angina within 6 months before the first dose; no clinically symptomatic severe arrhythmia; and no congestive heart failure of New York Heart Association Class II or higher.
- Ability to understand the study and voluntarily provide written informed consent.
Who cannot join
- Esophageal cancer with a pathological type other than squamous cell carcinoma.
- Distant organ or distant lymph node metastasis identified by preoperative imaging, intraoperative exploration, or postoperative pathological examination, corresponding to M1 disease according to the American Joint Committee on Cancer staging system, Eighth Edition.
- No prior neoadjuvant therapy, or prior neoadjuvant therapy other than chemotherapy combined with immunotherapy, including neoadjuvant chemotherapy alone or neoadjuvant chemoradiotherapy.
- Use of an anti-PD-L1 antibody or another immune checkpoint inhibitor other than an anti-PD-1 antibody during neoadjuvant treatment.
- One or fewer, or more than four, cycles of neoadjuvant chemoimmunotherapy.
- A Grade 4 or higher immune-related adverse event, Grade 3 or higher immune-related pneumonitis, or Grade 2 or higher immune-related myocarditis during prior neoadjuvant treatment, according to the Common Terminology Criteria for Adverse Events, Version 5.0.
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- Substantial extranodal extension, fixed or matted regional lymph nodes, or involvement of important surrounding tissues or organs found during surgery that, in the investigator's judgment, prevented complete oncological resection or created a clear risk of residual disease; or postoperative evidence of R1 or R2 resection.
- Major pathological response or pathologically negative regional lymph nodes (ypN0) after neoadjuvant treatment.
- A severe postoperative complication of Grade 3 or higher that has not recovered to Grade 1 or lower or to the preoperative baseline before planned adjuvant treatment or within 10 weeks after surgery; or a postoperative complication that, in the investigator's judgment, has substantially reduced the participant's performance status and is expected to prevent tolerance of adjuvant treatment.
- Poor nutritional status or a Patient-Generated Subjective Global Assessment score ≥9.
- An unhealed wound, ulcer, or fracture.
- Any Grade 2 or higher bleeding event within 4 weeks before the first dose.
- Evidence of a bleeding diathesis; current thrombolytic therapy or therapeutic anticoagulation; or use of an antiplatelet drug, such as clopidogrel, or high-dose aspirin >325 mg/day within 14 days before the first dose. Low-dose aspirin ≤100 mg/day for cardiovascular prevention is permitted.
- An arterial or venous thromboembolic event within 6 months before the first dose, including cerebrovascular accident, transient ischemic attack, deep vein thrombosis, or pulmonary embolism.
- A concurrent second primary malignancy or a history of another malignancy within the previous 5 years, except completely cured cervical carcinoma in situ, basal cell carcinoma of the skin, or squamous cell carcinoma of the skin.
- Active autoimmune disease, or a history of autoimmune disease that currently requires systemic immunosuppressive treatment. Stable thyroid dysfunction that does not require systemic immunosuppression, including hypothyroidism controlled with hormone replacement or stably controlled hyperthyroidism, is permitted.
- An active infection requiring systemic treatment; active tuberculosis; or a history of tuberculosis without adequate treatment and with current evidence of active disease. A participant with latent tuberculosis infection may be enrolled only after assessment by an infectious disease or respiratory specialist confirms that enrollment is safe.
- An uncontrolled active viral or sexually transmitted infection, including hepatitis B surface antigen positivity with hepatitis B virus DNA above the institutional lower limit of detection when standard antiviral therapy has not been initiated or cannot be administered following specialist assessment; uncontrolled hepatitis C virus RNA positivity; known HIV infection without standard antiviral treatment or with inadequate virological control; or active syphilis.
- Known severe hypersensitivity to an active ingredient or excipient of either study treatment.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Single-Arm Study of Adjuvant Immunotherapy Plus Anlotinib in Patients With Locally Advanced Esophageal Squamous Cell Carcinoma With Non-Major Pathological Response and ypN-Positive Disease After Neoadjuvant Chemoimmunotherapy and Surgery
The goal of this clinical trial is to learn whether postoperative immunotherapy combined with anlotinib can help prevent or delay cancer recurrence in adults aged 18 to 75 years with locally advanced esophageal squamous cell carcinoma. Eligible participants must have previously received chemotherapy combined with anti-PD-1 immunotherapy, followed by complete surgical removal of the cancer. Examination of the surgical specimens must show more than 10% viable tumor remaining in the original tumor bed and cancer cells remaining in regional lymph nodes.
The main questions this trial aims to answer are:
Read more
- What proportion of participants are alive without cancer recurrence or a second primary cancer 12 months after enrollment?
- How long do participants remain free of cancer recurrence, and how long do they survive?
- What treatment-related medical problems occur during treatment with anti-PD-1 immunotherapy plus anlotinib?
- Where does the cancer recur if recurrence occurs? All participants will receive the same study treatment; there is no comparison group.
Participants will:
- Receive an anti-PD-1 immunotherapy medicine by intravenous infusion once every 3 weeks, generally using the same anti-PD-1 medicine received before surgery
- Take anlotinib by mouth once daily for 14 days, followed by 7 days without anlotinib, in each 21-day treatment cycle
- Continue treatment for up to 15 cycles unless the cancer returns, unacceptable side effects occur, consent is withdrawn, or another reason for stopping treatment arises
- Undergo regular clinic visits, laboratory tests, physical examinations, and safety assessments during treatment
- Undergo imaging examinations approximately every 3 months to check for cancer recurrence
- Be followed for disease recurrence and survival for up to 5 years after surgery Stored surgical tumor tissue will also be studied to explore whether features of the tumor immune environment are associated with treatment outcomes.
- Conditions
- Esophageal Squamous Cell Carcinoma
- Being tested
- Anlotinib, Anti-PD-1 Monoclonal Antibody
- Keywords
- Anlotinib, Non-Major Pathological Response, ypN-Positive Disease, Adjuvant Therapy, Neoadjuvant Chemoimmunotherapy
- 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.
AnlotinibDrug
Anlotinib will be administered orally at a starting dose of 12 mg once daily on Days 1-14 of each 21-day cycle. Treatment will begin concurrently with anti-PD-1 immunotherapy within 10 weeks after surgery and continue for up to 15 cycles unless disease recurrence, unacceptable toxicity, withdrawal of consent, or another protocol-defined discontinuation criterion occurs. Dose interruptions and reductions to 10 mg and 8 mg once daily are permitted according to protocol-defined toxicity management criteria.
Anti-PD-1 Monoclonal AntibodyDrug
An anti-PD-1 monoclonal antibody will be administered by intravenous infusion on Day 1 of each 21-day cycle, generally using the same anti-PD-1 agent administered during neoadjuvant treatment. Treatment will begin within 10 weeks after surgery and continue for up to 15 cycles unless disease recurrence, unacceptable toxicity, withdrawal of consent, or another protocol-defined discontinuation criterion occurs. Dose reduction is not permitted; treatment-related toxicity will be managed by treatment interruption or permanent discontinuation according to the protocol.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | Participants will receive an anti-PD-1 monoclonal antibody by intravenous infusion on Day 1 of each 21-day cycle, generally using the same anti-PD-1 agent administered during neoadjuvant treatment. Anlotinib will be administered orally at a starting dose of 12 mg once daily on Days 1-14 of each 21-day cycle. Study treatment must begin within 10 weeks after surgery and will continue for up to 15 cycles unless disease recurrence, unacceptable toxicity, withdrawal of consent, or another protocol-defined reason for discontinuation occurs. Protocol-specified treatment interruptions and dose reductions of anlotinib to 10 mg or 8 mg are permitted for toxicity. Dose reduction of the anti-PD-1 agent is not permitted. Receives: Drug: Anlotinib; Drug: Anti-PD-1 Monoclonal Antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-Year Disease-Free Survival Rate
The Kaplan-Meier estimated percentage of participants who are alive without local or regional recurrence, distant metastasis, or a second primary malignancy at 12 months after enrollment. Disease-free survival is measured from the date of enrollment to the first occurrence of disease recurrence, a second primary malignancy, or death from any cause, whichever occurs first.
Measured: At 12 months after enrollment
Secondary outcomes (4)
Disease-Free Survival
Time from enrollment to the first documented local or regional recurrence, distant metastasis, second primary malignancy, or death from any cause, whichever occurs first. Participants without an event will be censored at the date of the last disease assessment.
Measured: From enrollment through 5 years after surgery
Overall Survival
Time from enrollment to death from any cause. Participants who are alive at the time of analysis will be censored at the date they were last known to be alive.
Measured: From enrollment through 5 years after surgery
Patterns of Disease Recurrence
The number and percentage of participants experiencing local recurrence, regional lymph node recurrence, or distant metastasis, as determined by imaging and pathological examination when clinically indicated. A participant may be included in more than one recurrence category if recurrence occurs at multiple sites.
Measured: From enrollment through 5 years after surgery
Percentage of Participants With Treatment-Related Adverse Events
The percentage of participants experiencing adverse events considered by the investigator to be related to anti-PD-1 immunotherapy, anlotinib, or their combination. Adverse events will be classified and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0. Grade 3 or higher treatment-related adverse events and adverse events of special interest will also be summarized.
Measured: From the first dose through completion or discontinuation of study treatment, up to 15 cycles (each cycle is 21 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2029 (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 Shanghai Chest 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Chest Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Liu, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07830355
- Sponsor's protocol ID
- IS26139
- Status last verified
- Sep 2026
- First submitted
- 10 Sep 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm Study of Adjuvant Immunotherapy Plus Anlotinib in Patients With Locally Advanced Esophageal Squamous Cell Carcinoma With Non-Major Pathological Response and ypN-Positive Disease After Neoadjuvant Chemoimmunotherapy and Surgery
- ClinicalTrials.gov ID
- NCT07830355
- Acronym / sponsor ID
- IS26139
- Conditions
- Esophageal Squamous Cell Carcinoma
- Keywords
- Anlotinib, Non-Major Pathological Response, ypN-Positive Disease, Adjuvant Therapy, Neoadjuvant Chemoimmunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 21 Sep 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.
The goal of this clinical trial is to learn whether postoperative immunotherapy combined with anlotinib can help prevent or delay cancer recurrence in adults aged 18 to 75 years with locally advanced esophageal squamous cell carcinoma. Eligible participants must have previously received chemotherapy combined with anti-PD-1 immunotherapy, followed by complete surgical removal of the cancer. Examination of the surgical specimens must show more than 10% viable tumor remaining in the original tumor bed and cancer cells remaining in regional lymph nodes.
The main questions this trial aims to answer are:
- What proportion of participants are alive without cancer recurrence or a second primary cancer 12 months after enrollment?
- How long do participants remain free of cancer recurrence, and how long do they survive?
- What treatment-related medical problems occur during treatment with anti-PD-1 immunotherapy plus anlotinib?
- Where does the cancer recur if recurrence occurs? All participants will receive the same study treatment; there is no comparison group.
Participants will:
- Receive an anti-PD-1 immunotherapy medicine by intravenous infusion once every 3 weeks, generally using the same anti-PD-1 medicine received before surgery
- Take anlotinib by mouth once daily for 14 days, followed by 7 days without anlotinib, in each 21-day treatment cycle
- Continue treatment for up to 15 cycles unless the cancer returns, unacceptable side effects occur, consent is withdrawn, or another reason for stopping treatment arises
- Undergo regular clinic visits, laboratory tests, physical examinations, and safety assessments during treatment
- Undergo imaging examinations approximately every 3 months to check for cancer recurrence
- Be followed for disease recurrence and survival for up to 5 years after surgery Stored surgical tumor tissue will also be studied to explore whether features of the tumor immune environment are associated with treatment outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Drug: Anlotinib, Drug: Anti-PD-1 Monoclonal AntibodyParticipants will receive an anti-PD-1 monoclonal antibody by intravenous infusion on Day 1 of each 21-day cycle, generally using the same anti-PD-1 agent administered during neoadjuvant treatment. Anlotinib will be administered orally at a starting dose of 12 mg once daily on Days 1-14 of each 21-day cycle. Study treatment must begin within 10 weeks after surgery and will continue for up to 15 cycles unless disease recurrence, unacceptable toxicity, withdrawal of consent, or another protocol-defined reason for discontinuation occurs. Protocol-specified treatment interruptions and dose reductions of anlotinib to 10 mg or 8 mg are permitted for toxicity. Dose reduction of the anti-PD-1 agent is not permitted. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Age 18 to 75 years, inclusive.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Histologically confirmed locally advanced esophageal squamous cell carcinoma.
- Prior treatment with 2 to 4 cycles of neoadjuvant chemotherapy combined with an anti-PD-1 monoclonal antibody, followed by radical surgery with pathologically confirmed R0 resection.
- An interval of no more than 10 weeks between completion of the last neoadjuvant chemotherapy or immunotherapy treatment and radical surgery.
Key exclusion criteria (19 listed)
- Esophageal cancer with a pathological type other than squamous cell carcinoma.
- Distant organ or distant lymph node metastasis identified by preoperative imaging, intraoperative exploration, or postoperative pathological examination, corresponding to M1 disease according to the American Joint Committee on Cancer staging system, Eighth Edition.
- No prior neoadjuvant therapy, or prior neoadjuvant therapy other than chemotherapy combined with immunotherapy, including neoadjuvant chemotherapy alone or neoadjuvant chemoradiotherapy.
- Use of an anti-PD-L1 antibody or another immune checkpoint inhibitor other than an anti-PD-1 antibody during neoadjuvant treatment.
- One or fewer, or more than four, cycles of neoadjuvant chemoimmunotherapy.
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 |
|---|---|---|
| AnlotinibAnlotinib will be administered orally at a starting dose of 12 mg once daily on Days 1-14 of each 21-day cycle. Treatment will begin concurrently with anti-PD-1 immunotherapy within 10 weeks after surgery and continue for up to 15 cycles unless disease recurrence, unacceptable toxicity, withdrawal of consent, or another protocol-defined discontinuation criterion occurs. Dose interruptions and reductions to 10 mg and 8 mg once daily are permitted according to protocol-defined toxicity management criteria. | Drug | Experimental Arm |
| Anti-PD-1 Monoclonal AntibodyAn anti-PD-1 monoclonal antibody will be administered by intravenous infusion on Day 1 of each 21-day cycle, generally using the same anti-PD-1 agent administered during neoadjuvant treatment. Treatment will begin within 10 weeks after surgery and continue for up to 15 cycles unless disease recurrence, unacceptable toxicity, withdrawal of consent, or another protocol-defined discontinuation criterion occurs. Dose reduction is not permitted; treatment-related toxicity will be managed by treatment interruption or permanent discontinuation according to the protocol. | Drug | Experimental Arm |
Primary outcome
1-Year Disease-Free Survival Rate
Time frame: At 12 months after enrollment
The Kaplan-Meier estimated percentage of participants who are alive without local or regional recurrence, distant metastasis, or a second primary malignancy at 12 months after enrollment. Disease-free survival is measured from the date of enrollment to the first occurrence of disease recurrence, a second primary malignancy, or death from any cause, whichever occurs first.
4 secondary outcomes
Disease-Free Survival
Time frame: From enrollment through 5 years after surgery
Overall Survival
Time frame: From enrollment through 5 years after surgery
Patterns of Disease Recurrence
Time frame: From enrollment through 5 years after surgery
Percentage of Participants With Treatment-Related Adverse Events
Time frame: From the first dose through completion or discontinuation of study treatment, up to 15 cycles (each cycle is 21 days).
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 21 Sep 2026.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anlotinib and Anti-PD-1 Monoclonal Antibody in people with Esophageal Squamous Cell Carcinoma, run by Shanghai Chest Hospital.
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: opening soon, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Jun Liu, Dr (+86 18930859538, drjunliuplus@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-Year Disease-Free Survival Rate (time frame: At 12 months after enrollment). 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 21 Sep 2026.