3773 - Definitive Radiotherapy with Systematic Therapy: Curative-Intent Treatment for Oligometastatic Cervical Cancer: A Single-Arm, Phase 2 Trial
Presenter(s)
J. Liu1, W. Tang1, G. Pan1, Q. Wu1, Q. Guo1, B. Liu1, X. Yan1, L. Zhang1, J. Wang2, Q. Zhu3, Y. Song4, and P. Xie1; 1Department of Radiation Oncology, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, China, 2Department of Radiation Oncology, Zaozhuang Municipal Hospital, Zaozhuang, China, 3Affiliated Hospital of Jining Medical University(Shandong province), Jining, China, 4Department of Radiation Oncology, Yantai Yuhuangding Hosptial, Yantai, China
Purpose/Objective(s): Recurrent or metastatic cervical cancer (r/mCC) poses the greatest therapeutic challenge. For those with oligometastatic disease, intensive combination regimens may offer superior outcomes. This study evaluated the clinical benefit of combining definitive radiotherapy for oligometastatic lesions with Iparomlimab (anti-PD-1) and Tuvonralimab (anti-CTLA-4) (QL1706) in patients with r/mCC.
Materials/Methods: This multicenter, phase 2, single-arm, open-label trial included patients aged 18–75 years with r/mCC (squamous cell or adenocarcinoma) in 4 institutions in China. Patients experienced locoregional recurrence or distant oligometastatic (with a total of =5 recurrent and metastatic lesions) after primary treatment were included. Treatment consisted of 4–6 cycles of QL1706 plus TP/TC chemotherapy (paclitaxel with cisplatin/carboplatin), followed by definitive radiotherapy (IMRT, IMPT, SBRT, or brachytherapy) and QL1706, and then QL1706 maintenance. The primary endpoint was progression-free survival (PFS), with treatment given until progression, unacceptable toxicity, or consent withdrawal. Safety was assessed in patients who received at least one dose of study treatment. This study is registered with Clinical Trials. NCT06942416.
Results: This analysis reports the preliminary results. From February to October 2025, 28 patients with r/mCC were enrolled, including 15 with locoregional recurrence and 13 with distant metastasis. Among them, 2 patients withdrew due to personal reasons. As of February 2026, 23 patients remain on treatment, of whom 6 cases have not yet reached the time for definitive radiotherapy. PD-L1 expression status was evaluable in 25 patients, with 3 exhibiting CPS < 1, 16 exhibiting CPS of 1–10, and 6 exhibiting CPS > 10. The median follow-up time was 6.25 months. Efficacy was evaluated in 22 patients with results as follows: complete response (CR) in 8, partial response (PR) in 12, stable disease (SD) in 1 and 1 patients were not evaluable (NE), yielding an objective response rate (ORR) of 90.91% (20/22). No disease progression has been observed to date. The disease control rate (DCR) was 100%. The median PFS for these patients was more than 8.73 months. The most common grade 3–4 adverse events were lymphocyte count decrease (20/28), followed by white blood cell decrease (10/28) and neutrophil count decrease (9/28). Immune-related adverse events included: grade 1 immune-related pneumonitis in 2/28 patients (7.1%); a psoriasis recurrence in 1 patient; renal failure in 1/28 patients; and thyroid dysfunction in 9/28 patients. No treatment-related deaths occurred.
Conclusion: The combination of QL1706 with definitive radiotherapy was well tolerated in patients with oligometastatic r/mCC. The current survival outcomes demonstrate promising efficacy, suggesting that this more aggressive treatment strategy may effectively delay disease progression in this patient population.