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Esophageal Cancer (EC)Phase 2NCT07863141

A Phase II Study of Anlotinib + PD-1 Inhibitor vs. PD-1 Inhibitor Maintenance After First-Line Chemoimmunotherapy in Advanced ESCC (Esophageal Squamous Cell Carcinoma)

A Phase 2 study testing anlotinib + PD-1 inhibitor and PD-1 inhibitor in people with Esophageal Cancer (EC), run by Sun Yat-sen University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Chemotherapy combined with PD-1 inhibitor immunotherapy is the standard treatment for advanced esophageal squamous cell carcinoma (ESCC), yet patient prognosis remains unsatisfactory, with a median PFS of only about 6 months and a 1-year PFS rate of only 25%. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Esophageal Cancer (EC)
What is being tested?
anlotinib + PD-1 inhibitor and PD-1 inhibitor
Could I receive a placebo?
No, everyone receives an active treatment
How many people
112 participants
Where
1 siteChina
Study dates
12 Oct 2026to 31 Oct 2031
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

  • Pathologically confirmed esophageal squamous cell carcinoma;
  • Unresectable locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma that has not received prior systemic therapy, or recurrence more than 6 months after completion of (neo)adjuvant/radical therapy;
  • Patients who have completed 4-6 cycles of PD-1 inhibitor combined with platinum-based doublet chemotherapy, who may receive local therapy if the investigator determines a benefit from local treatment, and who have not progressed after the above treatment;
  • Enrollment window: randomization must be performed within 42 days after completion of the last treatment (including local therapy);
  • Expected survival greater than 3 months;
  • Age 18-75 years;
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  • ECOG performance status score of 0-1;
  • Laboratory tests within 7 days before the first dose must meet the following requirements: Hematology: neutrophils ≥1.5×10^9/L, platelets ≥75.0×10^9/L, hemoglobin ≥80 g/L; Liver function: total bilirubin ≤1.5 × ULN, ALT/AST ≤2.5 × ULN (≤5 × ULN if liver metastasis is present); Renal function: serum creatinine ≤1.5 × ULN or creatinine clearance >60 mL/min; Coagulation function: international normalized ratio (INR) or prothrombin time (PT) ≤1.5 × ULN; no concomitant severe organic disease;
  • The patient understands the details of the trial and has signed the informed consent form.

Who cannot join

  • Known or suspected allergy to the study drug or to any drug administered in connection with this trial;
  • Patients who can be cured by surgery or radiotherapy;
  • Endoscopic or imaging findings indicating obvious deep ulceration of the esophageal lesion; or obvious invasion of adjacent vital organs (such as the aorta or trachea) by the tumor with a very high risk of bleeding or perforation; or formation of an esophageal-tracheal fistula/esophageal-mediastinal fistula;
  • Presence of complete esophageal obstruction requiring interventional treatment; prior esophageal or tracheal stent placement before enrollment; or presence of factors that significantly affect the absorption of oral drugs (anlotinib), such as inability to swallow tablets, chronic diarrhea, or intestinal obstruction;
  • Prior treatment with anlotinib; or treatment with other VEGF small-molecule tyrosine kinase inhibitors (TKIs) within 6 months before the first dose (Note: patients who received other VEGF TKIs during (neo)adjuvant/radical therapy and whose last dose was more than 6 months before this recurrence/progression may be enrolled);
  • Patients who experienced grade ≥3 immune-related adverse events (irAEs) during PD-1 inhibitor combined with chemotherapy, or for whom the investigator considers continued PD-1 inhibitor treatment inappropriate due to toxicities;
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  • Presence of symptomatic brain metastases or meningeal metastases (Note: patients whose brain metastases have been locally treated and remained stable for at least 4 weeks before enrollment without the need for glucocorticoids to reduce intracranial pressure may be allowed to enroll);
  • Patients with a history of other malignancies besides esophageal cancer before enrollment, except for melanoma skin cancer, carcinoma in situ of the cervix, or cured early-stage prostate cancer;
  • Poor blood pressure control despite antihypertensive medication (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg); or patients using two or more antihypertensive drugs to control blood pressure; patients with a history of hypertensive crisis or hypertensive encephalopathy;
  • Severe cardiovascular disease: myocardial infarction, severe/unstable angina, NYHA class III-IV heart failure, left ventricular ejection fraction (LVEF) <50% on echocardiography, severe arrhythmia requiring pharmacological intervention, or prior coronary/peripheral artery bypass grafting within 6 months before enrollment;
  • Bleeding tendency: clinically significant active bleeding within 2 months before screening (such as gastrointestinal bleeding, hematemesis, melena, etc., with a daily blood loss ≥2.5 mL); or patients with abnormal coagulation function, a bleeding tendency, or currently receiving thrombolytic or anticoagulant therapy (except prophylactic use of low-dose aspirin or low-molecular-weight heparin);
  • History of thrombosis: arterial or venous thrombotic events within 6 months before enrollment, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis, or pulmonary embolism;
  • High renal risk: patients with urine protein ≥++ on urinalysis and confirmed 24-hour urinary protein >1.5 g;
  • Surgery and trauma: major surgery (such as thoracotomy or laparotomy) within 4 weeks before the first dose, or presence of long-term non-healing wounds or fractures, or expected need for major surgery during the study period;
  • Active infection: presence of active infection requiring intravenous systemic anti-infective therapy, or known active tuberculosis;
  • Immune-related deficiency: known history of immunodeficiency, including positive HIV test, or other acquired or congenital immunodeficiency diseases, or a history of solid organ transplantation;
  • Female patients who are pregnant or breastfeeding;
  • Investigator's judgment: presence of severe concomitant diseases (such as uncontrolled diabetes, severe liver or kidney disease, etc.), psychiatric disorders, or psychological, family, social, or other factors that the investigator considers may jeopardize patient safety and compliance.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yong Bao, MD contact

8602087338692

baoyong@mail.sysu.edu.cn

China1 site, 1 recruiting

  • The First Affiliated Hospital of Sun Yat-sen University

    Guangzhou, Guangdong, 510000

    Yong Bao, MD, 8602087338692, baoyong@mail.sysu.edu.cn

    Yong Bao, MD

    Recruiting

Other trials in China

About this study

Official title: A Randomized, Multicenter, Open-label, Phase II Study of Maintenance Anlotinib Plus PD-1 Inhibitor Versus PD-1 Inhibitor Alone in Patients With Advanced Esophageal Squamous Cell Carcinoma Without Progression After First-line Chemoimmunotherapy

Chemotherapy combined with PD-1 inhibitor immunotherapy is the standard treatment for advanced esophageal squamous cell carcinoma (ESCC), yet patient prognosis remains unsatisfactory, with a median PFS of only about 6 months and a 1-year PFS rate of only 25%. Adding anlotinib maintenance therapy on top of PD-1 inhibitor immunotherapy maintenance after chemoimmunotherapy may improve progression-free survival and overall survival. We plan to conduct a randomized, multicenter, open-label Phase II study of anlotinib combined with PD-1 inhibitor maintenance therapy versus PD-1 inhibitor monotherapy maintenance in advanced ESCC. A total of 112 patients with unresectable locally advanced, recurrent, or metastatic ESCC are planned to be enrolled. After enrollment, patients will receive either anlotinib combined with PD-1 inhibitor maintenance therapy or PD-1 inhibitor monotherapy maintenance, with a maximum treatment duration of 2 years. This study aims to evaluate the efficacy and safety of anlotinib combined with PD-1 inhibitor maintenance therapy in advanced ESCC by comparing it with the PD-1 inhibitor monotherapy maintenance group, further optimizing the comprehensive treatment model for esophageal cancer.

Being tested
anlotinib + PD-1 inhibitor, PD-1 inhibitor
Keywords
Esophageal Cancer, Immunotherapy, Anlotinib
Medical subject headings
Esophageal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • anlotinib + PD-1 inhibitorDrug

    PD-1 inhibitor, 200 mg/240 mg, intravenous infusion, d1, Q3W; Anlotinib: 10 mg, qd, oral, d1-14, Q3W; Repeated every 3 weeks, for 2 years or until disease progression or intolerable toxicity

  • PD-1 inhibitorDrug

    PD-1 inhibitor, 200 mg/240 mg, intravenous infusion, d1, Q3W; Repeated every 3 weeks, for 2 years or until disease progression or intolerable toxicity

Study groups in NCT07863141
Study groupRoleWhat they receive
Anlotinib + PD-1 inhibitor maintenance therapy armExperimentalAnlotinib combined with immunotherapy maintenance therapy
Receives: Drug: anlotinib + PD-1 inhibitor
PD-1 inhibitor maintenance therapy armOtherImmunotherapy monotherapy maintenance therapy
Receives: Drug: PD-1 inhibitor

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival

    The time from enrollment until the first occurrence of documented disease progression or death from any cause, whichever occurs first.

    Measured: From enrollment to the end of treatment at 12 months

Secondary outcomes (5)

  1. Progression-free survival 2

    The time from enrollment to the first occurrence of disease progression on the next line of subsequent therapy or death from any cause, whichever occurs first.

    Measured: From enrollment to the end of treatment at 12 months

  2. Overall survival

    The time from enrollment until death from any cause.

    Measured: From enrollment to the end of treatment at 12 months

  3. DoR (Duration of Response)

    The time from enrollment or the first documentation of objective tumor response (complete response [CR] or partial response [PR]) to the first occurrence of documented disease progression or death from any cause, whichever occurs first.

    Measured: From enrollment to the end of treatment at 12 months.

  4. Treatment-related adverse events

    Incidence of treatment-related adverse events as assessed by CTCAE v5.0.

    Measured: From enrollment to the end of treatment at 12 months.

  5. Quality of Life

    Quality of life was assessed using the EORTC QLQ-C30 questionnaire.

    Measured: From enrollment to the end of treatment at 12 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Oct 2026
  2. Study start12 Oct 2026 (estimated)
  3. Primary completion31 Oct 2029 (estimated)
  4. Study completion31 Oct 2031 (estimated)

Resources

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
112 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07863141
Sponsor's protocol ID
MAINTAIN-ESCC II
Status last verified
Sep 2026
First submitted
29 Sep 2026
Last updated
7 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing anlotinib + PD-1 inhibitor and PD-1 inhibitor in people with Esophageal Cancer (EC), run by Sun Yat-sen University 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 9 inclusion and 18 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 7 Oct 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 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 Yong Bao, MD (8602087338692, baoyong@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (time frame: From enrollment to the end of treatment at 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07863141.

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 7 Oct 2026.

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