Adebrelimab in Combination With Apatinib and Chemotherapy/Chemoradiotherapy in Immuno-experienced Second-line ESCC.

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorThe First Affiliated Hospital of Henan University of Science and Technology

About this trial

To assess the efficacy and safety of adebrelimab in combination with apatinib mesylate and chemoradiotherapy in immuno-experienced second-line esophageal squamous cell carcinoma (with symptomatic dysphagia or oligometastatic disease),and to evaluate the efficacy and safety of adebrelimab in combination with apatinib mesylate and chemoradiotherapy in immuno-experienced second-line esophageal squamous cell carcinoma (without symptomatic dysphagia or oligometastatic disease).

Eligibility criteria

Qualifiers

1. Age 18-75 years old, male or female; 2. Esophageal squamous cell carcinoma confirmed by histology or cytology; 3. Patients who have progressed or are intolerant to first-line chemotherapy combined with immunotherapy (chemotherapy regimen can include platinum, purple shirt or fluorouracil as the basis, etc.) (progression of maintenance therapy after first-line chemotherapy combined with immunization can also be included).

Symptomatic dysphagia, Mellow score ≥1 (Mellow score: 0 = able to eat all solid foods, 1 = only partially solid foods, 2 = able to eat soft foods, 3 = only able to drink liquids, 4 = complete dysphagia);

Hypometastatic disease: Oligometastatic disease is considered when there are ≤ 3 metastases in the liver, lungs, retroperitoneal lymph nodes, adrenal glands, soft tissues, bones, or brain. In addition, after receiving a median of 18 weeks of systemic therapy, metastatic lesions are considered to be oligometastatic lesions at the time of restaging if they do not progress or only progress in size. If the number of lesions increases when restaged after systemic therapy, it is not considered oligometastatic disease.

Disqualifiers

1. Patients have any active autoimmune disease or history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism; patients with vitiligo; asthma that has been completely relieved in childhood and does not require any intervention in adulthood can be included; asthma patients requiring medical intervention with bronchodilators cannot be included); 2. The patient is using immunosuppressants, or systemic hormone therapy to achieve the goal of immunosuppression (dose> 10mg/day prednisone or other effective hormones), and continues to use it within 2 weeks before enrollment; 3. Patients with esophageal squamous cell carcinoma whose primary lesion is active hemorrhage; 4. Those with a variety of factors that affect oral medication (such as inability to swallow, gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc.); 5. Patients with brain metastases with symptoms or symptomatic control time of less than 3 months; 6. Patients with any severe/uncontrolled disease, including: patients with unsatisfactory blood pressure control (systolic blood pressure ≥150mmHg or diastolic blood pressure ≥100 mmHg); Patients with grade I or grade myocardial ischemia or myocardial infarction, arrhythmias (including QT interval ≥480ms) and grade I cardiac insufficiency, active or uncontrolled serious infections, liver disease such as decompensated liver disease, active hepatitis B (HBV-DNA≥ 104 copies/ml or 2000IU/ ml) or hepatitis C (positive for hepatitis C antibody and HCV-RNA above the lower limit of detection of the analytical method), urinalysis shows urine protein ≥++, and 24-hour urine protein quantification >1.0g; 7. Long-term unhealed wounds or fractures; 8. Pulmonary hemorrhage with NCI CTCAE grade >1 within 4 weeks prior to enrollment; bleeding from other sites with NCI CTCAE grade >2 within 4 weeks prior to enrollment; patients with bleeding tendencies (such as active peptic ulcers) or patients who are receiving thrombolytic or anticoagulant therapy such as warfarin, heparin, or their analogues; 9. Patients who have had arterior/venous thrombotic events within 6 months, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism; 10. Patients whose imaging shows that the tumor has invaded important blood vessels or who are judged by the investigator to have a high probability of invading important blood vessels during the follow-up study period, causing fatal hemorrhage; 11. Pregnant or lactating women; 12. Patients with other malignant tumors within 5 years (except for basal cell carcinoma of the skin and carcinoma in situ of the cervix that have been cured); 13. Patients with a history of psychotropic drug abuse who cannot be abstained from or patients with mental disorders; 14. Patients who have participated in clinical trials of other drugs within four weeks; 15. According to the judgment of the investigator, patients with concomitant diseases that seriously endanger the safety of patients or affect the completion of the study; 16. Those who, in the opinion of the investigator, are not suitable for inclusion.

Trial design

Treatments tested in this trial

  • Adebrelimab
  • Apatinib
  • Investigator chosen chemotherapy (ICC)
  • Radiotherapy

Treatment groups

54 Participants
are divided into 2 treatment groups