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New treatment option for Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma
Official title Combination Immunotherapy of Adebrelimab With Apatinib and Tegafur, Gimeracil and Oteracil Potassium Capsules for Immune Rechallenge Therapy in Esophageal Squamous Cell Carcinoma
ClinicalTrials.gov ID: NCT06339619
What this study is testing
What is Adebrelimab?
Adebrelimab is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for locally advanced or metastatic esophageal squamous cell carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- ECOG PS score of 0 \~ 1.
- Expected survival ≥3 months.
- Patients who have failed first-line immunotherapy combined with chemotherapy.
You likely can't join if
- Have been diagnosed with other malignancies within 5 years, excluding: curable carcinoma in situ of the cervix, skin basal cell carcinoma or squamous...
- 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...
- Have not recovered from adverse events caused by prior antitumor therapy (i.e., ≤ grade 1 or at baseline).
- people 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.
See the full eligibility criteria
- 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 (people with intracranial lesions alone were excluded from this study).
- 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...
- 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...
- people voluntarily participate in the study after fully informed consent and sign the informed consent.
- 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...
- Have not recovered from adverse events caused by prior antitumor therapy (i.e., ≤ grade 1 or at baseline).
- people 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.
- 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...
- 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.