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Locally Advanced or Metastatic Esophageal Squamous Cell CarcinomaPhase 2NCT06339619

Combination Immunotherapy of Adebrelimab With Apatinib and Tegafur, Gimeracil and Oteracil Potassium Capsules for Immune Rechallenge Therapy in Esophageal Squamous Cell Carcinoma

A Phase 2 study testing Adebrelimab, Apatinib and Tegafur in people with Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma, run by Sun Yat-Sen Memorial Hospital of 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

The goal of this single-arm study is to explore the efficacy and safety of Adebrelimab in combination with Apatinib and Tegafur for the treatment of locally advanced or metastatic esophageal squamous cell carcinoma that has failed first-line standard treatment with PD-1 inhibitors in combination with chemotherapy. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Adebrelimab, Apatinib and Tegafur
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteChina
Study dates
11 Mar 2024to 1 Sep 2028
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

  • 18-75 years old, both sexes.
  • Esophageal squamous cell carcinoma confirmed by histology or cytology with locally advanced unresectable or distant metastasis (according to AJCC 8th edition).
  • ECOG PS score of 0 ~ 1.
  • Expected survival ≥3 months.
  • Patients who have failed first-line immunotherapy combined with chemotherapy.
  • At least one measurable or unmeasurable lesion according to RECIST V1.1 criteria (subjects with intracranial lesions alone were excluded from this study).
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  • Ability to swallow investigational drugs .
  • The functional level of the organ must meet the following requirements. (1) ANC≥1.5×109/L; (2) PLT≥100×109/L; (3) Hb≥90 g/L; (4) Serum albumin ≥30 g/L; (5) TBIL≤1.5×ULN; ALT and AST≤2.5 x ULN; For patients with liver metastases, ALT and AST≤5×ULN; (6) Cr ≤1.5×ULN, or creatinine clearance ≥50mL/min as calculated by the Cockcroft-Gault formula; (7) Patients with urinary protein ≥++ should undergo further 24-hour quantitative detection of urinary protein, and the detection result should be<1.0g.
  • Within 7 days prior to enrollment, women of reproductive age must confirm a negative serum pregnancy test and consent to use effective contraception during the study drug use period and within 2 months after the last dose.
  • Subjects voluntarily participate in the study after fully informed consent and sign the informed consent.

Who cannot join

  • Have been diagnosed with other malignancies within 5 years, excluding: curable carcinoma in situ of the cervix, skin basal cell carcinoma or squamous cell carcinoma, or any other tumor that has been cured .
  • Patients who had previously received treament of Adebrelimab, Apatinib or Tegafur.
  • The following conditions occurred in the previous treatment history. (1)Used Chinese medicine anti-tumor treatment within 2 weeks; (2)Received other anti-tumor therapy within 4 weeks, including but not limited to chemotherapy, radiotherapy, and targeted therapy.
  • Have not recovered from adverse events caused by prior antitumor therapy (i.e., ≤ grade 1 or at baseline).
  • Subjects who have participated in or are participating in other clinical trials within 4 weeks.
  • Received major surgery within 4 weeks or anticipated to undergo major surgery during the study period.
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  • Subject is currently using a CYP3A strong inhibitor or inducer, or has discontinued a strong inhibitor for less than 5 half-lives of the medication or discontinued a strong inducer for less than 5 half-lives of the medication or 14 days (whichever is longer) before dosing.
  • Current need for treatment of central nervous system metastases or uncontrolled central nervous system metastases.
  • Risk of severe bleeding or esophageal fistula.
  • Clinically significant gastrointestinal abnormalities that may affect the intake, transport, or absorption of the drug.
  • Those with active gastrointestinal ulcers, active gastrointestinal bleeding, or perforation.
  • Within the 12 months prior to enrollment, individuals with any of the following conditions: myocardial infarction, coronary artery bypass grafting or peripheral artery bypass grafting surgery, congestive heart failure (III-IV graded by New York Heart Association), etc.; unstable angina within the 6 months prior to enrollment.
  • Within the 12 months prior to enrollment, occurrence of thrombotic events or embolic events, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis, pulmonary embolism, etc., or patients currently receiving thrombolytic or anticoagulant therapy such as warfarin, heparin, or other similar medications.
  • Fridericia-corrected QT interval (QTcF)>470 ms; history of congenital long QT syndrome; history of any clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or torsades de pointes); left ventricular ejection fraction (LVEF) <50%.
  • Those with uncontrollable pleural effusion, pericardial effusion, pelvic effusion, or ascites requiring repeated drainage.
  • Past or current interstitial lung disease or immune-related pneumonia; currently suffering from drug-induced pneumonia, radiation pneumonia requiring steroid therapy, or clinically symptomatic active pneumonia, or other moderate to severe pulmonary diseases severely affecting lung function.
  • Active infection during screening, or unexplained fever>38.5°C within 2 weeks prior to randomization.
  • Active hepatitis B or hepatitis C.
  • Received live vaccines within 4 weeks prior toenrollment and/or planned to receive live vaccines after enrollment.
  • Those with congenital or acquired immunodeficiency (such as HIV-infected individuals).
  • History of organ transplantation or allogeneic bone marrow transplantation.
  • Individuals deemed by the investigator to have other serious acute or chronic illnesses unsuitable for participation in the clinical trial.

Trial locations and contacts

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

Minghui Wang contact

+86 13826276828

wmingh@mail.sysu.edu.cn

China1 site, 1 recruiting

  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    Guangzhou, Guangdong, 510030

    Minghui Wang, Dr., 13826276828, wmingh@mail.sysu.edu.cn

    Minghui Wang, Dr.

    Recruiting

Other trials in China

About this study

Official title: Phase II Clinical Study of Adebrelimab Combined With Apatinib and Tegafur, Gimeracil and Oteracil Potassium Capsules in the Treatment of Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma That Failed First-line Immunotherapy Combined With Chemotherapy

The goal of this single-arm study is to explore the efficacy and safety of Adebrelimab in combination with Apatinib and Tegafur for the treatment of locally advanced or metastatic esophageal squamous cell carcinoma that has failed first-line standard treatment with PD-1 inhibitors in combination with chemotherapy.

Read the detailed description

Background: Although immune combined chemotherapy has established its position as the first-line standard treatment for locally advanced unresectable or metastatic esophageal cancer, resistance and disease progression inevitably occur in most patients. While earlier studies have shown some therapeutic advantages of the combination of PD-1/PDL1 inhibitors with anti-angiogenic drugs, the efficacy as a second-line treatment remains unsatisfactory, necessitating further exploration of combination therapies such as chemotherapy.We conduct this single-arm study is to explore the efficacy and safety of Adebrelimab in combination with Apatinib and Tegafur in treating the patients with locally advanced or metastatic esophageal squamous cell carcinoma who has failed first-line standard treatment with PD-1 inhibitors in combination with chemotherapy.

Method: This is a prospective single arm two-stage phase II study, with an intended enrollment of 32 patients. Eligible patients with esophageal squamous cell carcinoma will receive Adebrelimab at a dose of 20mg/kg, on day 1 via intravenous drip every 21 days, in combination with Apatinib at a dose of 250mg orally once daily on days 1-21 every 21 days, and Tegafur orally once daily on days 1-21 every 21 days（BSA<1.25m2,40mg; BSA=1.25～1.5m2,50mg;BSA>1.5m2, 60mg）. Each treatment cycle lasts for 21 days. Treatment will continue until disease progression, intolerable toxicity, withdrawal of informed consent, or death. Imaging evaluation for efficacy will be conducted every 6 to 8 weeks (±7 days) after the start of the initial treatment until disease progression, death, initiation of new anticancer therapy, withdrawal of informed consent, loss to follow-up, or study termination. The primary endpoint is objective response rate (ORR), and secondary endpoints include progression-free survival (PFS), overall survival (OS), disease control rate (DCR), and safety.

Being tested
Adebrelimab, Apatinib, Tegafur
Keywords
immunotherapy rechallenge, ESCC, Adebrelimab, First-line treatment failure
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.

  • AdebrelimabDrug

    20mg/kg ivgtt D1 Q3W

  • ApatinibDrug

    250mg PO QD

  • TegafurDrug

    dosing based on body surface area：BSA<1.25m2,40mg; BSA=1.25～1.5m2,50mg; BSA>1.5m2, 60mg，PO QD D1-21 Q3W

Study groups in NCT06339619
Study groupRoleWhat they receive
Adebrelimab+Apatinib+TegafurExperimentalNot described
Receives: Drug: Adebrelimab; Drug: Apatinib; Drug: Tegafur

What is being measured

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

  1. Objective response rate (ORR)

    ORR is determined as the percentage of patients who had complete response (CR) or partial response (PR) as best overall response per RECIST v1.1.

    Measured: 6 months

Secondary outcomes (3)

  1. Progression-free survival (PFS)

    PFS is determined as the duration from the start of treatment until disease progression or death from any cause, whichever occurs first.

    Measured: 6 months

  2. Overall survival (OS)

    OS is determined as the time from treatment to death.

    Measured: 12months

  3. ≥Grade 3 AEs

    The total incidence of grade 3 or greater adverse events was included.

    Measured: 6 months

Timeline

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

  1. First posted1 Apr 2024
  2. Study start11 Mar 2024
  3. Primary completion1 Mar 2028 (estimated)
  4. Study completion1 Sep 2028 (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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
32 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06339619
Sponsor's protocol ID
SYSKY-2023-1262-02
Status last verified
May 2026
First submitted
25 Mar 2024
Last updated
4 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Adebrelimab, Apatinib and Tegafur in people with Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma, run by Sun Yat-Sen Memorial Hospital of 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 10 inclusion and 22 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 4 Jun 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 Minghui Wang (+86 13826276828, wmingh@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (ORR) (time frame: 6 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 NCT06339619.

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 4 Jun 2026.

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