A Phase II Study to Evaluate the Efficacy and Safety of QL1706 Combination Therapy in Immunotherapy-Pretreated Recurrent or Metastatic Endometrial Cancer
This is a prospective, single-arm, multicenter Phase II study evaluating the efficacy and safety of QL1706 combined with chemotherapy in patients with advanced recurrent or metastatic endometrial cancer who progressed after prior anti-PD-1/L1 therapy.
• Age ≥18 years and ≤70 years.
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
• Recurrent or metastatic endometrial carcinoma, confirmed by pathology or imaging.
• At least one measurable tumor lesion according to RECIST v1.1 criteria.
• Patients must have received prior anti-PD-1/L1 monoclonal antibody (mAb) therapy with a progression-free survival (PFS) of ≥6 months; however, the last dose of anti-PD-1/L1 mAb must have been administered at least 5 half-lives before the initiation of the current treatment.
• Patients who have received prior anti-angiogenic therapy are eligible, provided there is a washout period of at least 5 half-lives before re-administration.
• Patients who have failed ≤2 lines of prior systemic therapy are eligible (endocrine therapy is not counted as a line of treatment).
• All other anti-tumor therapies must be discontinued at least 4 weeks before treatment initiation. Patients taking hormonal medications require a 30-day washout period.
• Laboratory tests during the screening period must demonstrate adequate organ function.
⁃ Female subjects of childbearing potential must have a negative serum pregnancy test within 3 days prior to the first dose. If a female subject of childbearing potential engages in sexual activity with a non-sterilized male partner, the subject must use an acceptable and highly effective contraceptive method since screening and must agree to continue such precautions until 6 months after the last dose of the study drug; periodic abstinence and the rhythm method are not acceptable forms of contraception.
⁃ Voluntarily sign the informed consent form, understand the nature, purpose, and procedures of the trial, and willingly comply with the trial requirements.