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Esophageal Squamous Cell CarcinomaPhase 2NCT04390958

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

A Phase 2 study testing nab-paclitaxel, Cisplatin and Capecitabine in people with Esophageal Squamous Cell Carcinoma, run by Chinese Academy of Medical Sciences at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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%. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Esophageal Squamous Cell Carcinoma
What is being tested?
nab-paclitaxel, Cisplatin and Capecitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteChina
Study dates
15 May 2020to Dec 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

Aiping Zhou, MD contact

8613691161998

Zhouap1825@126.com

China1 site, 1 recruiting

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

    Beijing

    Zhou Aiping, +86 13691161998, zhouap1825@126.com

    Recruiting

Other trials in China

About this study

Official title: 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.

Medical subject headings
Esophageal Squamous Cell Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04390958
Study groupRoleWhat they receive
Neoadjuvant chemotherapy groupExperimentalTotal 6 perioperative chemotherapy composed of nab-paclitaxel, cisplatin and capecitabine every 21 days
Receives: Drug: nab-paclitaxel; Drug: Cisplatin; Drug: Capecitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pathological complete response (pCR) rate

    No cancer cells in primary tumor and all lymph nodes resected are observed by pathologists

    Measured: 2 year

Secondary outcomes (9)

  1. Objective Response Rate (ORR)

    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)

    Measured: 2 year

  2. R0 resection rate

    The ratio of the patients with surgical R0 resection over the of patients who receive surgery

    Measured: 2 year

  3. Major Pathological Response (MPR) rate

    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

    Measured: 2 year

  4. Overall survival (OS)

    Time from enrollment to death

    Measured: From date of enrollment until the date of death from any cause, assessed up to 24 months

  5. Disease free survival (DFS)

    From the day of surgery with R0 resection to recurrence or death of any reasons

    Measured: From date of enrollment until the date of death or recurrence, assessed up to 24 months

  6. Progression-free survival (PFS)

    number of participant with disease progression

    Measured: 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

  7. Recurrence rate

    number of participant with disease recurrence

    Measured: 2 year

  8. Treatment-emergent adverse events

    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

    Measured: 2 year

  9. Surgical complications

    Measured: Within the first 90 days after the start of surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2020
  2. Study start15 May 2020
  3. Primary completionJun 2022 (estimated)
  4. Study completionDec 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04390958
Sponsor's protocol ID
NCC-003475
Status last verified
Mar 2022
First submitted
13 May 2020
Last updated
15 Mar 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Zhang W, Chen X, Xue L, Jiang Z, Qu D, Yang Z, Qin J, Wang Z, Zhang M, Li Y, Zhou A, Gao S. Neoadjuvant chemotherapy with albumin-bound paclitaxel plus cisplatin and capecitabine for locally advanced esophageal squamous cell carcinoma: a phase 2 clinical trial. Int J Surg. 2025 Jun 1;111(6):3831-3837. doi: 10.1097/JS9.0000000000002375. Epub 2025 May 12.

    PubMed 40358628

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing nab-paclitaxel, Cisplatin and Capecitabine in people with Esophageal Squamous Cell Carcinoma, run by Chinese Academy of Medical Sciences at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Aiping Zhou, MD (8613691161998, Zhouap1825@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathological complete response (pCR) rate (time frame: 2 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04390958, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2022.

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