- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07808853
Node-Sparing Short-Course Radiotherapy (25 Gy/5 Fractions) Combined With Chemoimmunotherapy as Neoadjuvant Treatment for Locally Advanced Esophageal Squamous Cell Carcinoma:A Prospective Single-Arm, Phase II Study (NeoSCRTIC-01)
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
The study is designed as a Simon optimal two-stage, single-arm phase II trial. The target sample size is 33 participants, allowing for approximately 10% attrition. In stage 1, 15 participants will be enrolled; if at least 4 achieve pathologic complete response, enrollment will proceed to stage 2. A further 15 evaluable participants will then be enrolled. The protocol considers the regimen promising if at least 15 of 30 evaluable participants achieve pathologic complete response.
Eligible participants are treatment-naive adults aged 18-75 years with PET-CT and pathologically confirmed thoracic esophageal squamous cell carcinoma, clinical stage cT1b-3N1-2M0 or cT2-3N0M0 (AJCC 9th edition), ECOG performance status 0-1, measurable disease by RECIST v1.1, and disease considered amenable to R0 resection.
Neoadjuvant treatment consists of camrelizumab 200 mg intravenously on Day 1 every 3 weeks plus nab-paclitaxel 260 mg/m² on Day 1 and carboplatin AUC 5 on Day 1 for three cycles. Short-course radiotherapy (25 Gy in 5 fractions over 5 days) is delivered after the first cycle, targeting only the primary tumor and positive lymph nodes and sparing elective lymphatic drainage regions. Tumor imaging is performed after the second cycle and before surgery. McKeown esophagectomy is planned 4-6 weeks after completion of neoadjuvant therapy when hematologic and organ function have recovered. Postoperative survival follow-up is planned every 3 months for 3 years.
Typ studie
Zápis (Odhadovaný)
Fáze
- Fáze 2
Kontakty a umístění
Studijní kontakt
- Jméno: Hongying Liao MD, Professor / Chief Physician, MD and PhD
- Telefonní číslo: +86-020-35919121
- E-mail: liaohy2@mail.sysu.edu.cn
Studijní místa
-
-
Guangdong
-
Guanzhou, Guangdong, Čína, 510655
- Nábor
- The Sixth Affiliated Hospital, Sun Yat-sen University
-
Kontakt:
- Hongying Liao MD, Professor / Chief Physician, MD and PhD
- Telefonní číslo: +86-020-35919121
- E-mail: liaohy2@mail.sysu.edu.cn
-
Kontakt:
- Jiayan Wu MD, MD and PhD
- Telefonní číslo: +86-020-35919121
- E-mail: wujy526@mail.sysu.edu.cn
-
Vrchní vyšetřovatel:
- Hongying Liao, MD
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Written informed consent before enrollment.
- Age 18 to 75 years, any sex.
- Treatment-naive esophageal squamous cell carcinoma confirmed by pathology and PET-CT.
- Clinical stage cT1b-3N1-2M0 or cT2-3N0M0 (stage II/III according to the AJCC 9th edition).
- Disease assessed as amenable to R0 surgical resection before treatment.
- At least one measurable lesion according to RECIST v1.1.
- ECOG performance status 0-1.
- Adequate organ function: absolute neutrophil count ≥1,500/mm³; platelets ≥100,000/mm³; hemoglobin ≥9 g/dL; serum creatinine ≤1.5 mg/dL and/or creatinine clearance ≥60 mL/min; bilirubin ≤1.5×ULN; AST and ALT ≤1.5×ULN; no blood components or hematopoietic growth factors within 14 days.
- For women of childbearing potential: medically accepted contraception during treatment and for 3 months afterward; negative serum or urine HCG within 7 days before enrollment; not breastfeeding.
- For men who are not surgically sterile: agreement to use medically accepted contraception with their partner during treatment and for 3 months afterward.
- Willingness to participate and comply with safety and survival follow-up.
Exclusion Criteria:
- Prior radiotherapy, chemotherapy, prolonged/high-dose corticosteroid therapy, surgery, or molecular targeted therapy.
- Previous or concurrent other malignancy.
- Prior PD-1/PD-L1 therapy; known allergy to macromolecular protein preparations or any component of PD-1 therapy.
- Active autoimmune disease or relevant autoimmune disease history as specified in the protocol.
- Immunosuppressive agents for immunosuppression within 2 weeks before enrollment.
- Symptomatic pleural or peritoneal effusion requiring therapeutic puncture or drainage.
- Poorly controlled clinically significant cardiac disease as specified in the protocol.
- Abnormal coagulation with bleeding tendency or thrombolytic/anticoagulant therapy.
- Recent gastrointestinal conditions associated with bleeding or perforation risk.
- Severe bleeding within 3 months, hemoptysis within 4 weeks, or thromboembolic event within 12 months according to protocol thresholds.
- Active infection or unexplained fever >38.5°C during screening or before first dose.
- Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 4 weeks before study treatment.
- History/current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonitis, or severe pulmonary dysfunction.
- Congenital/acquired immunodeficiency including HIV infection, or active hepatitis outside protocol-defined limits.
- Participation in another clinical study or completion of a previous clinical study within 1 month; anticipated need for other systemic anticancer therapy.
- Live vaccine within 4 weeks before study treatment or anticipated during the study.
- Known history of psychotropic drug abuse, alcohol abuse, or illicit drug abuse.
- Unable or unwilling to bear self-paid portions of study-related examinations or treatment.
- Any other condition considered by the investigator to compromise participant safety, study completion, or data/sample collection.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Neoadjuvant SCRT + Camrelizumab + Nab-Paclitaxel/Carboplatin
Participants receive three 3-week cycles of camrelizumab plus nab-paclitaxel and carboplatin.
Lymphatic-drainage-sparing short-course radiotherapy (25 Gy in 5 fractions over 5 days) is delivered after the first cycle.
McKeown esophagectomy is planned 4-6 weeks after completion of neoadjuvant treatment.
|
Participants receive three 3-week cycles of camrelizumab plus nab-paclitaxel and carboplatin. Lymphatic-drainage-sparing short-course radiotherapy (25 Gy in 5 fractions over 5 days) is delivered after the first cycle. McKeown esophagectomy is planned 4-6 weeks after completion of neoadjuvant treatment. Drug: Camrelizumab Camrelizumab 200 mg intravenously on Day 1 of each 3-week cycle for 3 cycles. Drug: Nab-paclitaxel Nab-paclitaxel 260 mg/m² intravenously on Day 1 of each 3-week cycle for 3 cycles. Drug: Carboplatin Carboplatin AUC 5 intravenously on Day 1 of each 3-week cycle for 3 cycles. Radiation: Short-course radiotherapy 25 Gy in 5 fractions over 5 days, delivered to the primary tumor and radiographically positive lymph nodes while elective lymphatic drainage regions are spared. Procedure: McKeown esophagectomy McKeown esophagectomy with thoracoabdominal two-field lymph node dissection, planned 4-6 weeks after completion of neoadjuvant therapy (maximum extension of 2 additional |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Pathologic Complete Response (pCR) Rate
Časové okno: At definitive surgery, approximately 4-8 weeks after completion of neoadjuvant therapy.
|
Percentage of participants undergoing definitive surgery who have no residual viable tumor in the resected primary tumor and regional lymph nodes, defined in the protocol as ypT0N0.
|
At definitive surgery, approximately 4-8 weeks after completion of neoadjuvant therapy.
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Major Pathologic Response (MPR) Rate
Časové okno: At definitive surgery, approximately 4-8 weeks after completion of neoadjuvant therapy.
|
Major pathologic response (MPR) is defined as ≤10% residual viable tumor cells in the primary esophageal tumor resection specimen, regardless of lymph node status, as pre-specified in study protocol.
The percentage of participants achieving this protocol-defined MPR criterion in post-neoadjuvant surgical resection specimen will be calculated.
|
At definitive surgery, approximately 4-8 weeks after completion of neoadjuvant therapy.
|
|
Objective Response Rate (ORR)
Časové okno: From baseline to the preoperative tumor assessment, approximately 9-15 weeks after initiation of neoadjuvant therapy.
|
Percentage of participants with complete response or partial response according to RECIST v1.1 based on protocol-specified imaging assessments.
|
From baseline to the preoperative tumor assessment, approximately 9-15 weeks after initiation of neoadjuvant therapy.
|
|
R0 Resection Rate
Časové okno: Upon completion of final postoperative pathological assessment, expected within 7 days post-operatively
|
Percentage of participants undergoing esophagectomy with microscopically negative resection margins.
|
Upon completion of final postoperative pathological assessment, expected within 7 days post-operatively
|
|
Disease-Free Survival (DFS) Rate
Časové okno: 1 year and 3 years after surgery.
|
Disease-free survival rate at 1 and 3 years.
|
1 year and 3 years after surgery.
|
|
Overall Survival (OS) Rate
Časové okno: 1 year and 3 years after surgery.
|
Overall survival rate at the specified time points.
Survival will be estimated using the Kaplan-Meier method.
|
1 year and 3 years after surgery.
|
Spolupracovníci a vyšetřovatelé
Publikace a užitečné odkazy
Obecné publikace
- van Hagen P, Hulshof MC, van Lanschot JJ, Steyerberg EW, van Berge Henegouwen MI, Wijnhoven BP, Richel DJ, Nieuwenhuijzen GA, Hospers GA, Bonenkamp JJ, Cuesta MA, Blaisse RJ, Busch OR, ten Kate FJ, Creemers GJ, Punt CJ, Plukker JT, Verheul HM, Spillenaar Bilgen EJ, van Dekken H, van der Sangen MJ, Rozema T, Biermann K, Beukema JC, Piet AH, van Rij CM, Reinders JG, Tilanus HW, van der Gaast A; CROSS Group. Preoperative chemoradiotherapy for esophageal or junctional cancer. N Engl J Med. 2012 May 31;366(22):2074-84. doi: 10.1056/NEJMoa1112088.
- Pennathur A, Gibson MK, Jobe BA, Luketich JD. Oesophageal carcinoma. Lancet. 2013 Feb 2;381(9864):400-12. doi: 10.1016/S0140-6736(12)60643-6.
Užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 2026ZSLYEC-647
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .