A Trial of SHR-1210 (an Anti-PD-1 Inhibitor) in Combination With Hypofraction Radiotherapy in Patients With NSCLC
A Phase II Clinical Trial of SHR-1210 (an Anti-PD-1 Inhibitor) Simultaneously Combined With Hypofraction Radiotherapy in Patients With Previously Treated Oligometastatic NSCLC
This is a phase II clinical trial of SHR-1210 (an anti-PD-1 Inhibitor) simultaneously combined with hypofraction radiotherapy in patients with previously treated oligometastatic NSCLC.
It is a single center, single arm, open label trial. Subjects with oligometastatic non-small-cell lung cancer who is previously treated will be recruited. 12 subjects will be enrolled at the first part of the study which aims to evaluate the tolerability of SHR-1210 in combination with hypofraction radiotherapy. 30 subjects will be enrolled at the second part of the study which aims to evaluate the primary efficacy and safety of SHR-1210 in combination with hypofraction radiotherapy.
調査の概要
研究の種類
入学 (予想される)
段階
- フェーズ2
連絡先と場所
研究場所
-
-
Shandong
-
Jinan、Shandong、中国、250117
- 募集
- Shandong Cancer Hospital and Institute
-
コンタクト:
- Jinming Yu, PhD
- 電話番号:13806406293
- メール:sdyujinming@126.com
-
コンタクト:
- Xiangjiao Meng, PhD
- 電話番号:13793150996
- メール:mengxiangjiao@126.com
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Subjects will voluntarily participate in this study and sign informed consent.
- NSCLC subject with 1 to 5 distant metastatic lesions in stage IV.
- No clear driven genes (including but not limited to EGFR, ALK).
- Previously received more than 1 chemotherapy regimen and progressed/recurred.
- At least one lesion is suitable for hypofraction radiotherapy.
- There is at least one measurable lesion.
- 18 to 75 years old
- ECOG 0-1
- The function of vital organs meets the following requirements. ANC≥1.5×10^9/L, PLT≥100×10^9/L, Hb≥9g/dL, ALB≥3g/dL, TSH ≤ULN, Bilirubin ≤ 1 times ULN; ALT and AST ≤1.5 times ULN. AKP ≤ 2.5 times ULN. CREA ≤1.5 times ULN or CCr≥60mL/min。
- The estimated survival period is more than 3 months.
- Female Subjects of childbearing potential must have a negative serum pregnancy test within 72 hours before the first dose and must be willing to use very efficient barrier methods of contraception for the course of the study through 3 months after the last dose of study treatment.
Exclusion Criteria:
- The subjects had any history of autoimmune disease or active autoimmune disease.
- Subjects are using immunosuppressive agents, or systemic, or absorptive, local hormone therapy to achieve immunosuppression.It is still in use within 2 weeks of the entry.
- Subjects with severe allergic reactions to other monoclonal antibodies.
- The subjects had a central nervous system metastases of clinical symptoms.
- Central squamous cell lung carcinoma.
- Imaging (CT or MRI) shows that tumors invade large blood vessels or are indistinct with blood vessels.
- Imaging (CT or MRI) showed significant pulmonary vacuity or necrotic tumors,Borderline adenocarcinoma accompanied by a cavity can be considered after discussion with investigator.
- Failing to properly control the clinical symptoms or disease of the heart.
- Subjects had active infections.
- Subjects may receive other systemic antitumor therapy during the study period.
- Other clinical trials of drugs were used in the first four weeks of the first medication.
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:SHR-1210 +Hypofraction radiotherapy
SHR-1210 (an Anti-PD-1 Inhibitor) Simultaneously Combined with Hypofraction Radiotherapy
|
SHR-1210 (an Anti-PD-1 Inhibitor) Simultaneously Combined with Hypofraction Radiotherapy
他の名前:
|
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 |
---|---|---|
Clinically significant toxicity
時間枠:First cycle (28 days)
|
above grade 3 AEs
|
First cycle (28 days)
|
6-month-PFS
時間枠:From the start of treatment to 6 months.
|
6-month-progression free survival rate
|
From the start of treatment to 6 months.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
OS
時間枠:2年まで
|
OSは、治療の開始から何らかの理由または追跡調査の喪失により死亡するまでの時間間隔です。
|
2年まで
|
PFS
時間枠:2年まで
|
無増悪サバイバル
|
2年まで
|
AEs+SAEs
時間枠:from the first drug administration to within 30 days for the last SHR-1210 dose
|
Adverse Events and Serious Adverse Events
|
from the first drug administration to within 30 days for the last SHR-1210 dose
|
ORR
時間枠:At baseline,at the time point of every 8 weeks
|
Objective Response Rate
|
At baseline,at the time point of every 8 weeks
|
DCR
時間枠:at the time point of every 8 weeks
|
Disease Control Rate
|
at the time point of every 8 weeks
|
協力者と研究者
捜査官
- 主任研究者:JINGMIN YU, PhD、Shandong Cancer Hospital and Institute
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
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
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。
非小細胞肺がんの臨床試験
-
Adelphi Values LLCBlueprint Medicines Corporation完了肥満細胞性白血病 (MCL) | 攻撃的な全身性肥満細胞症 (ASM) | SM w Assoc Clonal Hema Non-mast Cell Lineage Disease (SM-AHNMD) | くすぶり全身性肥満細胞症 (SSM) | 無痛性全身性肥満細胞症 (ISM) ISM サブグループが完全に募集されましたアメリカ
SHR-1210の臨床試験
-
Tianjin Medical University Cancer Institute and...まだ募集していません
-
Qian ChuJiangsu HengRui Medicine Co., Ltd.募集
-
The First Affiliated Hospital of Zhengzhou Universityまだ募集していません切除可能な食道扁平上皮がん
-
Harbin Medical UniversityJiangsu HengRui Medicine Co., Ltd.わからないHCC | NSCLC | CRC