Efficacy and Safety of QL1706 Combined With Nab-paclitaxel and Cisplatin as 1st Line Therapy for … (NCT07533305) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Efficacy and Safety of QL1706 Combined With Nab-paclitaxel and Cisplatin as 1st Line Therapy for Advanced or Metastatic Esophageal Squamous Cell Carcinoma
50 participantsStarted 2026-05-01
Plain-language summary
The purpose of this study is to assess the efficacy and safety of QL1706 combined with nab-paclitaxel and cisplatin in first-line therapy for patients with advanced or metastatic esophageal squamous cell carcinoma. QL1706 is a anti-PD-1 and anti-CTLA4 antibody.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* Subjects participate voluntarily and sign informed consent.
* 18-75 years, male or female.
* Histologically confirmed Unresectable Advanced or metastatic Esophageal Squamous Cell Carcinomas
* No previous systemic anti-tumor treatment for unresectable locally advanced or metastatic esophageal squamous cell carcinoma has been received
* At least 1 measurable target lesion and/or unmeasurable target lesion according to Response Evaluation in Solid Tumors (RECIST 1.1).
* ECOG PS 0-1
* Expected survival ≥ 12 weeks
* Adequate organ function (without blood transfusion or growth factors within 14 days prior to first dose), including: ANC ≥ 1.5 × 10⁹/L; Platelets ≥ 100 × 10⁹/L; Hemoglobin ≥ 90 g/L; Serum albumin ≥ 30 g/L; Total bilirubin ≤ 1.5 × ULN; ALT/AST ≤ 2.5 × ULN (≤ 5 × ULN if with liver or bone metastases); ALP ≤ 2.5 × ULN; Serum creatinine ≤ 1.5 × ULN; INR ≤ 1.5 (if not on anticoagulation);
* Non-sterilized women of childbearing potential and male participants with such partners must agree to use medically approved contraception during and for 3 months after study drug administration. Women must test negative for serum or urine HCG within 7 days prior to first dose and not be breastfeeding
Exclusion Criteria:
* Have received anti-PD-1 or anti-PD-L1 antibody therapy;
* BMI \< 18.5 kg/m2 or weight loss ≥ 10% within 2 months before screening (at the same time, the effect of a large amount of pleural effusions and ascites on bogy weight should be consider…
What they're measuring
1
ORR
Timeframe: From the date of first dose to achieving complete response or partial response, assessed up to 42 months
Trial details
NCT IDNCT07533305
SponsorThe First Affiliated Hospital of Henan University of Science and Technology