A Phase II Single-arm Clinical Study in the Treatment of Locally Advanced Esophageal Cancer After… (NCT07530549) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Phase II Single-arm Clinical Study in the Treatment of Locally Advanced Esophageal Cancer After Failed Neoadjuvant Chemoimmunotherapy
40 participantsStarted 2026-04-01
Plain-language summary
The goal of this clinical trial is Iparomlimab and tuvonralimab (QL1706) combined with chemoradiotherapy in the treatment of locally advanced esophageal cancer after failed neoadjuvant chemoimmunotherapy. The main question it aims to answer is: Can it bring survival benefits and safet to patients?Subsequent evaluation will determine whether the patient undergoes surgical treatment. Follow-up will be conducted to assess the efficacy and safety of the treatment。
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* Age 18 to 75 years, male or female;
* Histologically confirmed locally advanced squamous cell carcinoma or adenocarcinoma of the esophagus or esophagogastric junction;
* ECOG performance status 0-1; ④ Failure of or local progression after 2-4 cycles of first-line chemotherapy combined with immunotherapy, or deemed unresectable by surgical evaluation;
⑤ At least one measurable lesion according to RECIST v1.1 criteria;
⑥ Adequate major organ and bone marrow function: Hematology: Hemoglobin (Hb) ≥90 g/L (without transfusion within 14 days); Absolute neutrophil count (NEUT) ≥1.5×10⁹/L; Platelets (PLT) ≥100×10⁹/L; Biochemistry: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN (≤5×ULN in cases of liver metastases); Total bilirubin (TBIL) ≤2×ULN; Serum albumin (ALB) ≥28 g/L; Serum creatinine (Cr) ≤1.5×ULN and creatinine clearance \>50 μmol/L; Coagulation: International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤1.5×ULN (unless the subject is receiving anticoagulant therapy and INR and APTT are within the expected therapeutic range);
⑦ Effective contraception during the study period;
* Voluntary participation in this study with signed informed consent and good compliance.
Exclusion Criteria:
* Active bleeding or high risk of bleeding (as assessed by the investigator);
* Patients requiring systemic anti-infective therapy;
* Concurrent primary malignant tumors o…
What they're measuring
1
Event-free Survival(EFS)
Timeframe: From enrollment to the end of monitoring at 2 years
Trial details
NCT IDNCT07530549
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences