QL1706 Combined With Cisplatin/Paclitaxel as Neoadjuvant Therapy for Cervical Cancer
A Phase II, Single-Arm Study of QL1706 Combined With Cisplatin/Paclitaxel as Neoadjuvant Therapy Prior to Conservative Surgery for FIGO 2018 Stage IB1-IB3 Cervical Cancer (CERVINA Study)
This is a prospective, single-arm, phase II clinical study designed to evaluate the efficacy and safety of QL1706 combined with cisplatin and paclitaxel as neoadjuvant therapy in patients with FIGO 2018 stage IB1-IB3 cervical cancer undergoing conservative surgery.
The primary endpoint is pathological complete response (pCR). Secondary endpoints include objective response rate (ORR), progression-free survival (PFS), overall survival (OS), 3-year pelvic recurrence rate, and safety profile.
Additionally, exploratory biomarker analyses will be conducted to investigate changes in immune status, genomic alterations, PD-L1 expression, tumor mutational burden, MSI-H/dMMR status, and vaginal microbiota before and after treatment.
調査の概要
詳細な説明
Cervical cancer remains one of the most common gynecologic malignancies worldwide. Neoadjuvant chemotherapy (NACT) has demonstrated favorable response rates in locally advanced cervical cancer; however, pathological complete response (pCR) rates remain limited.
QL1706 is a novel bifunctional PD-1/CTLA-4 antibody combination developed using the MabPair® platform. It consists of the anti-PD-1 antibody iparomlimab and the anti-CTLA-4 antibody tuvonralimab. Previous studies have demonstrated promising antitumor activity in recurrent or metastatic cervical cancer.
This study aims to investigate whether the addition of QL1706 to cisplatin/paclitaxel neoadjuvant therapy can improve pathological response and clinical outcomes in patients with FIGO 2018 stage IB1-IB3 cervical cancer undergoing conservative surgery.
Approximately 50 patients will be enrolled. Eligible patients will receive neoadjuvant QL1706 combined with cisplatin and paclitaxel followed by radical surgery. Efficacy will be evaluated using RECIST v1.1 and pathological assessment. Safety will be assessed according to CTCAE v5.0.
Exploratory translational studies will evaluate immune microenvironment changes, molecular biomarkers, and vaginal microbiota alterations associated with treatment response.
研究の種類
入学 (推定)
段階
- フェーズ2
連絡先と場所
研究連絡先
- 名前：Zhigang Zhang, MD
- 電話番号：86057189713631
- メール：zzg2011@zju.edu.cn
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Female patients aged 18-65 years.
- Histologically confirmed cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma.
- FIGO 2018 stage IB1, IB2, or IB3 cervical cancer.
- Pelvic MRI completed before enrollment.
- ECOG performance status of 0-2.
- Adequate organ and bone marrow function.
- No prior immunotherapy for malignant tumors.
- Ability to understand and willingness to sign written informed consent.
Exclusion Criteria:
- Presence of uncontrolled concomitant malignancies.
- Active autoimmune disease or history of autoimmune disease with potential recurrence.
- Interstitial lung disease or uncontrolled pneumonitis.
- Active hepatitis B or hepatitis C infection.
- Known HIV infection.
- Receipt of live vaccines within 30 days before first dose.
- Uncontrolled cardiovascular disease.
- Known hypersensitivity to study drugs.
- Any condition that, in the investigator's judgment, may interfere with study participation or interpretation of results.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Experimental Arm
QL1706 + Cisplatin/Paclitaxel Neoadjuvant Therapy
|
QL1706 is a bifunctional PD-1/CTLA-4 antibody combination consisting of iparomlimab and tuvonralimab. Drug: Cisplatin Cisplatin administered as part of neoadjuvant chemotherapy. Drug: Paclitaxel Paclitaxel administered as part of neoadjuvant chemotherapy. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Pathological Complete Response (pCR)
時間枠：At surgery following completion of neoadjuvant therapy
|
Proportion of patients achieving pathological complete response after neoadjuvant therapy.
|
At surgery following completion of neoadjuvant therapy
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Objective Response Rate (ORR)
時間枠：During neoadjuvant treatment period
|
Proportion of patients achieving complete or partial response according to RECIST v1.1.
|
During neoadjuvant treatment period
|
|
Progression-Free Survival (PFS)
時間枠：Up to 3 years
|
Time from treatment initiation to disease progression or death.
|
Up to 3 years
|
|
3-Year Pelvic Recurrence Rate
時間枠：3 years
|
Proportion of patients with pelvic recurrence within 3 years.
|
3 years
|
|
Adverse Events
時間枠：From informed consent through 30 days after last treatment dose
|
Incidence and severity of adverse events graded according to CTCAE v5.0.
|
From informed consent through 30 days after last treatment dose
|
|
Overall Survival (OS)
時間枠：Up to 3 years
|
Time from treatment initiation to death from any cause
|
Up to 3 years
|
協力者と研究者
捜査官
- 主任研究者：Jianwei Zhou, PhD、Second Affiliated Hospital, School of Medicine, Zhejiang University
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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