SCRT Combined With CAPOX and PD-1/CTLA4 Antibody for Early-stage Low Rectal Cancer
The Combination of PD-1/CTLA4 Antibody and Neoadjuvant Short-course Radiotherapy in Early-stage Low Rectal Cancer
The study evaluates the combination of immunotherapy of PD-1/ CTLA4 antibody and neoadjuvant short-course radiotherapy in early low rectal cancer. A total of 34 patients will receive 5*5Gy short-course radiotherapy, followed by 4 cycles of capecitabine plus oxaliplatin (CAPOX) chemotherapy and PD-1/ CTLA4 antibody, finally receive the local excision(TEM) or total mesorectal excision (TME). The rate of complete response (cCR+pCR), Organ retention rate, long-term prognosis, and adverse effects will be analyzed.
調査の概要
状態
条件
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：Zhen Zhang, M.D, PH.D
- 電話番号：18801735029 18801735029
- メール：zhen_zhang@fudan.edu.cn
研究場所
-
-
Shanghai Municipality
-
Shanghai、Shanghai Municipality、中国、200030
- Fudan University Shanghai Cancer Center
-
-
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:
- age 18-75 years old, female and male
- pathological confirmed adenocarcinoma
- clinical stage T1-3bN0, tumor maximum diameter less than 4cm
- the distance from anal verge less than 5 cm
- without distance metastases
- KPS >=70
- with good compliance
- microsatellite repair status is MSS/pMMR
- without previous anti-cancer therapy or immunotherapy
- signed the inform consent
Exclusion Criteria:
- pregnancy or breast-feeding women
- pathological confirmed signet ring cell carcinoma
- clinical stage T1N0 and can be resected locally
- history of other malignancies within 5 years
- serious medical illness, such as severe mental disorders, cardiac disease, uncontrolled infection, etc.
- immunodeficiency disease or long-term using of immunosuppressive agents
- baseline blood and biochemical indicators do not meet the following criteria: neutrophils≥1.5×10^9/L, Hb≥90g/L, PLT≥100×10^9/L, ALT/AST ≤2.5 ULN, Cr≤ 1 ULN
- DPD deficiency
- allergic to any component of the therapy
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：Treatment Arm
A total of 34 patients will receive 5*5Gy short-course radiotherapy, followed by 4 cycles of CAPOX chemotherapy and PD-1/CTLA4 antibody, finally receive the TEM or TME surgery. |
Shor-course radiotherapy: 25Gy/5Fx Iparomlimab and Tuvonralimab, 5mg/kg, d1 q3w Capecitabine: 1000mg/m2 d1-14 q3w 130mg/m2 d1 q3w |
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 |
|---|---|---|
|
complete response (CR) rate
時間枠：From date of receiving neoadjuvant therapy, assessed up to 2 years
|
Rate of complete response (CR), including the rate of pathologic complete response (pCR) after surgery and the rate of cCR with W&W strategy. |
From date of receiving neoadjuvant therapy, assessed up to 2 years
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Organ preservation rate
時間枠：From date of receiving neoadjuvant therapy, assessed up to 2 years
|
Rate of patients who underwent organ preservation via WW or TEM after neoadjuvant therapy |
From date of receiving neoadjuvant therapy, assessed up to 2 years
|
|
3 year disease free survival rate
時間枠：From date of initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
|
Rate of 3 year disease free survival |
From date of initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
|
|
3 year local recurrence free survival rate
時間枠：From date of initiation of treatment until the date of first documented pelvic failure, assessed up to 36 months.
|
Rate of 3 year local recurrence free survival |
From date of initiation of treatment until the date of first documented pelvic failure, assessed up to 36 months.
|
|
3 year overall survival rate
時間枠：From date of initiation of treatment until the date of death from any cause, assessed up to 36 months.
|
Rate of 3 year overall survival |
From date of initiation of treatment until the date of death from any cause, assessed up to 36 months.
|
|
10 year Quality of Life
時間枠：From date of initiation of treatment until the date of death from any cause, assessed up to 10 years
|
Patient self-assessment via EORTC QLQ-C30 questionnaire to monitor changes in quality of life throughout treatment. |
From date of initiation of treatment until the date of death from any cause, assessed up to 10 years
|
|
Grade 3-4 adverse effects rate
時間枠：From date of initiation of treatment until the date of death from any cause, assessed up to 5 years
|
Incidence and severity of treatment side effects graded by NCI CTCAE v5.0. |
From date of initiation of treatment until the date of death from any cause, assessed up to 5 years
|
協力者と研究者
スポンサー
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
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- FDRT-2026-306-5158
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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