PD-1 Antibody Plus Chemoradiotherapy for IB2-IIIB Cervical Cancer
2022年4月5日 更新者:Lei Li
Effectiveness and Safety of Camrelizumab Combined With Concurrent Chemoradiotherapy for FIGO IB2-IIIB Cervical Cancer: A Single-center, Single-arm, Open-phase II Clinical Study
This study is a single-center, single-arm, open-phase II clinical study, the main purpose of which is to evaluate the effectiveness and safety of camrelizumab combined with concurrent chemoradiotherapy for early and locally advanced cervical cancer, i.e., FIGO 2018 IB2-IIIB cervical cancer.
Eligible subjects will be given cisplatin and radiotherapy, for 6-8 weeks, camrelizumab repeated every 14 days until disease progression, toxicity intolerance, or other reasons specified in the protocol.
Subjects who finished treatment entered the safety follow-up or survival follow-up.
調査の概要
状態
募集
条件
研究の種類
介入
入学 (予想される)
92
段階
- フェーズ2
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
Beijing
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Beijing、Beijing、中国、100730
- 募集
- Lei Li
-
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
女性
説明
Inclusion Criteria:
- Histologically confirmed cervical adenocarcinoma, cervical squamous cell carcinoma, or cervical adenosquamous carcinoma and FIGO2018 IB2 to IIIB;
- Have not received radiotherapy, chemoradiotherapy or other'system therapy for,cervical,cancer in the past.
- With measurable tumor lesions (meet RECIST 1.1 standard).
- Age≥18 years old when signing the informed consent, female.
- ECOG PS: 0-2 points.
- Expected survival time > 6 months.
- According with lab testing criteria in the protocol.
- Ability and willingness to comply with research and follow-up procedures.
- Females of childbearing potential must agree to use adequate contraception throughout the study period and for 6 months after the end of treatment.
- The patients voluntarily joined the clinical study and signed the informed consent, with good compliance and follow-up.
Exclusion Criteria:
- Have previously received an anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody, or anti-CTLA-4 antibody (or any other antibody that acts on T cell costimulation or checkpoint pathways);
- Have a clear history of allergies, and may have potential allergies or intolerances to the study drug and its similar biological agents.
- Participated in clinical trials of other antitumor drugs within 4 weeks before the first dose, or planned to receive live attenuated vaccines within 4 weeks before the first dose or during the study.
- Other malignant tumors have occurred within 5 years (except for adequately treated cutaneous squamous cell carcinoma or controlled cutaneous basal cell carcinoma).
- Use immunosuppressive medications, excluding nasal and inhaled corticosteroids or physiologic doses of systemic steroids (no more than 10 mg/day prednisolone or other corticosteroids at equivalent doses),within 14 days of first use of camrelizumab.
- Symptomatic advanced patients with visceral dissemination who are at short-term risk of life-threatening complications (including uncontrolled massive exudates [thoracic, pericardium, abdominal], pulmonary lymphangitis and more than 30% patients with liver involvement).
- Presence or history of any active autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism; subjects with vitiligo or asthma in childhood have been completely relieved, no need for any after adulthood Asthma patients who need bronchodilator for medical intervention can not be included).
- Subjects with grade II or higher myocardial ischemia or myocardial infarction, and poorly controlled arrhythmias (including QTc interval ≥450ms in men and ≥470ms in women). According to the New York Heart Association standard, Subjects with grade III-IV cardiac insufficiency, or echocardiography showed left ventricular ejection fraction (LVEF) <50%; myocardial infarction occurred within 6 months before enrollment, and New York Heart Association grade II or above cardiac function Failure, uncontrolled angina, uncontrolled severe ventricular arrhythmia, clinically significant pericardial disease, or electrocardiogram suggesting acute ischemia or active conduction system abnormalities.
- Concurrent severe infection (eg, requiring intravenous antibiotics, antifungals, or antivirals) within 4 weeks prior to first dose, or unexplained fever >38.5°C during screening or before first dose.
- Subjects with a history of psychotropic substance abuse and unable to quit or with mental disorders.
- Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), active hepatitis B (HBV DNA ≥ 500 IU/ml), hepatitis C (hepatitis C antibody positive, and HCV-RNA is higher than the detection limit of the analytical method) or co-infection with hepatitis B and C.
- Subjects with untreated central nervous system metastases, Subjects who have received systemic, radical brain or meningeal metastases in the past (radiotherapy or surgery), have been stable for at least 1 month if confirmed by imaging, and have stopped systemic hormone therapy (Dose > 10mg/day prednisone or other equivalent therapeutic hormones) for more than 2 weeks and without clinical symptoms can be included.
- Subjects with a history of hereditary or acquired bleeding or coagulation dysfunction (the investigator will determine whether they can be included).
- Other conditions not considered suitable for inclusion by the researcher.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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 |
|---|---|
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実験的:Patients with primary IB2-IIIB cervical cancer
Patients with primary IB2-IIIB cervical cancer, including squamous carcinoma, adenocarcinoma, and adenosquamous carcinoma.
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Participants will be given intravenous administration of Camrelizumab (200mg,every 2 weeks),Cisplatin(40mg/m²,everyweek) and Radiotherapy.
After completing 6~8weeks of concurrent chemoradiation, the Participants will continue to use camrelizumab as maintenance therapy until disease progression or unacceptable toxicity.
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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 |
|---|---|---|
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3-year OS rate
時間枠:36 months
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Patient proportion to survival in the third year
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36 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Progression-free survival(PFS)
時間枠:24 months
|
The period of time between when a patient with neoplastic disease receives treatment and when the disease progresses or death from any cause occurs.
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24 months
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Objective response rate (ORR)
時間枠:12 months
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Refers to the proportion of patients whose tumors have shrunk to a certain amount and maintained for a certain period of time, including cases of complete remission(CR) and partial remission(PR).
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12 months
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Acute Adverse Events (AEs)
時間枠:36 months
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The number of participants who experience unacceptable toxicity during protocol treatment as measured by the NCI CTCAE version 5.0
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36 months
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2022年3月27日
一次修了 (予想される)
2023年3月27日
研究の完了 (予想される)
2026年3月27日
試験登録日
最初に提出
2022年3月27日
QC基準を満たした最初の提出物
2022年3月27日
最初の投稿 (実際)
2022年4月5日
学習記録の更新
投稿された最後の更新 (実際)
2022年4月13日
QC基準を満たした最後の更新が送信されました
2022年4月5日
最終確認日
2022年4月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。