Neoadjuvant Chemotherapy With Nab-paclitaxel Plus Cisplatin and Capecitabine for Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma

March 13, 2022 updated by: AIPING ZHOU, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Phase II Study of Neoadjuvant Chemotherapy With Nab-paclitaxel Plus Cisplatin and Capecitabine for Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Neoadjuvant chemotherapy group
Total 6 perioperative chemotherapy composed of nab-paclitaxel, cisplatin and capecitabine every 21 days
Drug: nab-paclitaxel
125mg/m2 ivgtt d1、d8
Drug: Cisplatin
60mg/m2 ivgtt d1 or d1-2
Drug: Capecitabine
1750mg/m2 po bid d1-14

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pathological complete response (pCR) rate
Time Frame: 2 year
No cancer cells in primary tumor and all lymph nodes resected are observed by pathologists
2 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: 2 year
Objective response rate is defined as the rate of patients with at least a 30% decrease in the sum of the LD (longest diameter) of target lesions, which include complete response (CR) or partial response (PR)
2 year
R0 resection rate
Time Frame: 2 year
The ratio of the patients with surgical R0 resection over the of patients who receive surgery
2 year
Major Pathological Response (MPR) rate
Time Frame: 2 year
MPR is defined as 10% or fewer viable cancer cells in the hematoxylin and eosin (H&E)-stained slides from the resected tumor following neoadjuvant treatment
2 year
Overall survival (OS)
Time Frame: From date of enrollment until the date of death from any cause, assessed up to 24 months
Time from enrollment to death
From date of enrollment until the date of death from any cause, assessed up to 24 months
Disease free survival (DFS)
Time Frame: From date of enrollment until the date of death or recurrence, assessed up to 24 months
From the day of surgery with R0 resection to recurrence or death of any reasons
From date of enrollment until the date of death or recurrence, assessed up to 24 months
Progression-free survival (PFS)
Time Frame: 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
number of participant with disease progression
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
Recurrence rate
Time Frame: 2 year
number of participant with disease recurrence
2 year
Treatment-emergent adverse events
Time Frame: 2 year
From the day of neoadjuvant therapy to 30 days after surgery or within 90 days after last neoadjuvant treatment. To evaluate the incidence of TEAE, rate of grade 3 and 4 TEAE (CTCAE 5.0), rate of surgery delay over 30 days and/or inoperable patients
2 year
Surgical complications
Time Frame: Within the first 90 days after the start of surgery
Within the first 90 days after the start of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Investigators

  • Principal Investigator: Shugeng Gao, MD, Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 15, 2020

Primary Completion (ANTICIPATED)

June 1, 2022

Study Completion (ANTICIPATED)

December 1, 2022

Study Registration Dates

First Submitted

May 13, 2020

First Submitted That Met QC Criteria

May 13, 2020

First Posted (ACTUAL)

May 18, 2020

Study Record Updates

Last Update Posted (ACTUAL)

March 15, 2022

Last Update Submitted That Met QC Criteria

March 13, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCC-003475

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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