NCT06885814Fut, nem toboroz2. fázis
Efficacy and Safety of Adebrelimab Combined With Chemoradiotherapy in Patients With Unresectable Locally Advanced or Postoperative Recurrent Esophageal Squamous Cell Carcinoma
A Phase II Clinical Study on the Efficacy and Safety of Adebrelimab Combined With Chemoradiotherapy in Patients With Unresectable Locally Advanced or Postoperative Recurrent Esophageal Squamous Cell Carcinoma
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. okt. 2.
Rövid összefoglaló (regiszter, angolul)
This study was a multi-center, single-arm, open-label phase II clinical trial. Thirty patients with unresectable locally advanced or postoperative recurrent esophageal squamous cell carcinoma were treated with concurrent chemoradiotherapy combined with immunotherapy. The radiotherapy regimen was intensity-modulated radiotherapy with PGTV at 50-50.4 Gy/25-28 fractions, 1.8-2 Gy per fraction, five times a week. The chemotherapy regimen was paclitaxel 50 mg/m2 and cisplatin 25 mg/m2 intravenous infusion on day 1, once a week for five times. The immunotherapy was with adebutilimab at 1200 mg on day 1, every three weeks for three times. One week before radiotherapy, gastroscopy, chest CT or PET-CT images were taken as the baseline standard. Based on the results of gastroscopy, chest CT or PET-CT before and after treatment, the number of patients with complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) in the two groups was observed. The objective response rate (ORR) was calculated as CR + PR, and the disease control rate (DCR) was calculated as CR + PR + SD. The progression-free survival (PFS), overall survival (OS), 1-year and 2-year survival rates and adverse reactions were also statistically analyzed.
- Állapot (regiszter)
- Fut, nem toboroz
- Fázis (regiszter)
- 2. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 30 (tervezett)
- Első benyújtás
- 2025. márc. 2.
- Kezdés
- 2024. jún. 6.
- Elsődleges befejezés
- 2026. nov. 1.
- Fő szponzor
- Nanfang Hospital, Southern Medical University
- Betegségek
- Gyomor- és nyelőcsőrák
- NCT-szám
- NCT06885814
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 2. fázis
- Tervezett résztvevők: 30
- 2024. jún. 6. és az elsődleges befejezés (2026. nov. 1.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Korábbi kezelés
- Other malignant tumors have been diagnosed within the previous 5 years
- Those who have previously received PD-1 or PD-L1 antibody therapy
- Patients receiving immunosuppressive drugs or corticosteroids >10mg/ day of prednisone therapeutic dose within 14 days prior to enrollment
- Patients who had received radiotherapy, chemotherapy, targeted therapy, or immunotherapy within 4 weeks prior to enrollment
Más betegség
- Lesions invading the trachea or large blood vessels, or investigators judge that there is a high risk of esophageal/tracheal fistula or bleeding
- Have any history of active autoimmune disease or autoimmune disease
- Have clinical symptoms or diseases of the heart that are not under control
- Active infection or fever (except definite tumor fever)
- History or evidence of interstitial lung disease or active non-infectious pneumonia
- Patients with immune dysfunction and active hepatitis
- Allergic to any drug in this protocol
Egyéb
- There is distant organ metastasis (according to AJCC stage, supraclavicular lymph node metastasis is M1, which should be excluded)
- Pregnant or lactating women
Kiket keres a vizsgálat
- Age 18-75 years old, gender unlimited
- Esophageal squamous cell carcinoma confirmed by histology and unresectable locally advanced or postoperative recurrence
- According to the solid tumor efficacy evaluation criteria (RECIST1.1), there is at least one measurable lesion; And the lesion had not received prior radiotherapy
- ECOG: 0~1
- Expected survival ≥12 weeks 6. Laboratory examination: neutrophils ≥1.5 x 109/L, platelets ≥100 x 109/L; Hemoglobin ≥ 9g/L; Albumin ≥ 2.8g/dL; Bilirubin ≤1.5 times ULN, ALT and AST≤2.5 times ULN
- 7: Subjects voluntarily joined the study, signed informed consent, had good compliance, and cooperated with follow-up 8: Tissue samples should be provided for biomarker analysis such as (PD-L1). Newly acquired tissues are preferred, and 15 5-6um thick paraffin sections can not be provided for archiving by the recent organizer
Életkor a regiszterben: 18 év – 75 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Nanfang Hospital, Southern Medical University | Guangzhou | Kína | Ismeretlen állapot |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.