Clinical trial NCT04390958: Neoadjuvant Chemotherapy With Nab-paclitaxel Plus Cisplatin and Capecitabine for Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma
Official title: Phase II Study of Neoadjuvant Chemotherapy With Nab-paclitaxel Plus Cisplatin and Capecitabine for Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Esophageal Squamous Cell Carcinoma
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
First posted: 2020-05-18
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Surgical resection is currently the major treatment for esophageal carcinoma while disease progression still occurred in most cases within 3 years. The rate of local recurrence and distant metastases could reach nearly 40% to 60%. The neoadjuvant chemotherapy could significantly improve resection rate and overall survival after surgery. Squamous cell carcinoma is the most common histology in Asia. JCOG9907 trial performed in Japan confirmed that compared to surgery plus adjuvant chemotherapy, the combination of neoadjuvant chemotherapy and surgery could further prolong overall survival. The regimen of cisplatin and fluorouracil is a classic effective option in combination therapy for esophageal carcinoma. Nanoparticle albumin-bound (nab)-paclitaxel is a novel taxane and has better efficacy in esophageal carcinoma treatment. We try to evaluate the efficacy and safety of neoadjuvant chemotherapy with nab-paclitaxel plus cisplatin and capecitabine for locally advanced thoracic esophageal squamous cell carcinoma patients.


Eligibility criteria: Inclusion Criteria:

* Histologic pathological or cytological diagnosis of squamous cell carcinoma of esophagus
* Age ranges from 18 to 70 years
* Patients must not have received any prior anticancer therapy
* Preoperative stage cT2N+M0, cT3-4aN0/N+M0 thoracic esophageal squamous cell carcinoma evaluated by MDT consultation based on imaging examinations
* Eastern cooperative oncology group (ECOG) performance status of 0 to 1
* Signed informed consent document on file
* Females with childbearing potential must have a negative serum pregnancy
* Adequate organ function to receive esophagectomy including the following:

Bone marrow: absolute white blood cells count ≥3.0×10\^9/L, absolute neutrophil count (ANC) ≥1.5×10\^9/L, platelets ≥100×10\^9/L, haemoglobin ≥90g/L; Hepatic: total bilirubin ≤1.5 times upper limit of normal (ULN), alanine transaminase (ALT) and aspartate transaminase (AST) ≤2.5 times ULN; Renal: calculated creatinine clearance rate≥80ml/min

* For childbearing potential males and females, who have agreed with contraception from start of investigational drug administration to 6 months after last dose of investigational drug
* Patients who have no contraindication of nab-paclitaxel, cisplatin or capecitabine

Exclusion Criteria:

* Patients who may develop tracheoesophageal fistula or aortoesophageal fistula
* Patients who have received allogeneic organ or stem cell transplants
* Patients with uncontrolled diabetes mellitus, any serious or unstable medical condition or mental illness
* Patients with preexisting or a history of ≥ Grade II peripheral neuropathy
* Pregnant or breast feeding
* Patients who take part in clinical trials of other drugs or biological therapy within 4 weeks before enrollment
* Prior invasive malignancy in 5 years (except for curable carcinoma in situ of cervix and non-melanoma skin cancer)
* Patients with digestive tract obstruction or metabolic dysfunction which may influence oral absorption of capecitabine
* Patients with supraclavicular lymph node metastasis, celiac lymph node metastasis except for pericardial and left gastric lymph node metastasis
* Patients with evidence of distant metastases

Primary outcomes:
measure: Pathological complete response (pCR) rate
timeFrame: 2 year
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: 2 year
measure: R0 resection rate
timeFrame: 2 year
measure: Major Pathological Response (MPR) rate
timeFrame: 2 year
measure: Overall survival (OS)
timeFrame: From date of enrollment until the date of death from any cause, assessed up to 24 months
measure: Disease free survival (DFS)
timeFrame: From date of enrollment until the date of death or recurrence, assessed up to 24 months
measure: Progression-free survival (PFS)
timeFrame: From date of enrolment until the date of first documented disease progression or date of death from any cause, whichever came first, assessed up to 24 months
measure: Recurrence rate
timeFrame: 2 year
measure: Treatment-emergent adverse events
timeFrame: 2 year
measure: Surgical complications
timeFrame: Within the first 90 days after the start of surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Study officials:
affiliation: Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
name: Shugeng Gao, MD
role: PRINCIPAL_INVESTIGATOR
References: