ClinicalTrials.gg
Not yet recruitingNCT06889402Updated Mar 21, 2025

Prognostic Analysis of Esophageal Cancer with Complete Pathological Response After Neoadjuvant Therapy

An observational study in Esophageal Cancer, sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-03-21.

Primary conditionEsophageal Squamous Cell CarcinomaRegistry: Esophageal NeoplasmsReclassifiedWhy we changed it
Registry
Esophageal Neoplasms — the first condition term the registry derived for this study.
ClinicalTrials.gg
Esophageal Squamous Cell Carcinoma
Why
  1. The study's title name Esophageal Squamous Cell Carcinoma, a narrower term within Esophageal Neoplasms.
Confidence
High: the new condition is named in the study's own title. Of 46 hand-checked studies reclassified this way, 72% were exactly right and 89% in the right disease family; the registry's first term was right for 4% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Observational

From the registry’s dates

  • Primary completion was expected by Apr 2025, 1 year 6 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
600
Ages
18 Years to 85 Years
Sex
All
01

Study summary

Esophageal cancer is one of the most common malignant tumors worldwide, with high invasiveness and lethality. Currently, the treatment for resectable locally advanced esophageal cancer mainly consists of a treatment model centered on surgical treatment with the participation of multiple disciplines. Neoadjuvant treatment regimens include chemotherapy, chemoradiotherapy, and chemotherapy combined with immunotherapy. Complete pathological response (pCR)is currently regarded as one of the important indicators for evaluating the efficacy of neoadjuvant treatment. Previous studies have shown that 14%-39% of patients with complete pathological response after neoadjuvant treatment still experience recurrence and metastasis within two years after surgery, suggesting that pCR after esophageal cancer surgery does not mean clinical cure. Perhaps there is a highly risk clinical subgroup need to research. Therefore, based on the prospective clinical database of the National Cancer Center and in cooperation with multiple national cancer regional medical centers, this study analyzes and explores the prognosis of patients with locally advanced esophageal squamous cell carcinoma with pCR after neoadjuvant treatment, characterized by the Chinese population.

02

Conditions studied

  • Esophageal Cancer

Keywords

  • Complete pathological response
  • neoadjuvant
  • Recurrence
  • Esophageal Squamous Cell Carcinoma
  • Survival
03

In context

Esophageal Squamous Cell Carcinoma Reclassified

675 studies on the registry are indexed under Esophageal Squamous Cell Carcinoma; 267 are open to participants now.

This study's planned enrollment of 600 is above the median of 247 across 86 observational studies indexed under Esophageal Squamous Cell Carcinoma.

Browse Esophageal Squamous Cell Carcinoma studies →

Lead sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences is the lead sponsor of 393 studies on the registry; 280 are open to participants now.

Compared within Esophageal Squamous Cell Carcinoma, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Esophageal Neoplasms. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with thoracic esophageal squamous cell carcinoma treated neoadjvant treatment followed by esophagectomy from 2018 to 2023,whose preoperative clnical stage was cT1N+M0/cT2-4aN0-3M0, with potential resectability and the ypstage ypT0N0M0(complete pathological response )

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients treated neoadjvant treatment followed by esophagectomy from 2018 to 2023
  • Patients with thoracic esophageal squamous cell carcinoma
  • The preoperative clnical stage is cT1N+M0/cT2-4aN0-3M0, with potential resectability
  • Patients with complete pathological response (ypT0N0M0)
  • Without distant was found in the preoperative examinations, and the tumor did not directly invade the pancreas, spleen, trachea, aorta or other adjacent organs such as the lungs

Exclusion criteria

Exclusion Criteria:

  • Patients with previous history of malignant tumors
  • Patients with multiple primary cancers
  • Deficient treatment or salvage surgery
  • Incomplete clinical data
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Adjuvant and neoadjuvant

Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
600 participants (estimated)
Patient registry
No

Groups and cohorts

  • Recurrence

    Patients with complete pathological response after neoadjuvant treatment experience recurrence or metastasis after surgery

    Procedure: Neoadjuvant therapy with PD-L1 inhibitor

  • Non-recurrence

    Patients with complete pathological response after neoadjuvant treatment without recurrence or metastasis after surgery

    Procedure: Neoadjuvant therapy with PD-L1 inhibitor

Interventions

  • ProcedureNeoadjuvant therapy with PD-L1 inhibitor

    During neoadjuvant treatment, patients may receive neoadjuvant chemotherapy, neoadjuvant chemoradiotherapy, or neoadjuvant chemotherapy combined with immunotherapy during the perioperative period.

    Also known as: neoadjuvant chemotherapy, neoadjuvant chemoradiotherapy

06

What researchers measure

Primary outcomes

  1. Disease-Free Survival

    The time from the postoperative period of the patient to the first occurrence of recurrence or metastasis.

    Time frame: The postoperative follow-up period should last for at least one year.

Secondary outcomes

  1. Overall Survival Rate

    the proportion of patients who are still alive for a certain period of time after surgery among all the patients who have undergone the surgical operation.

    Time frame: The postoperative follow-up period should last for at least one year.

Other outcomes

  1. Metastasis rate of different parts or organs

    Time frame: The postoperative follow-up period should last for at least one year.

07

Study locations

1 site
  • Section of Esophageal and Mediastinal Oncology, Department of Thoracic Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
    Beijing, Beijing 100021, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 21, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06889402
Responsible party
Sponsor
First posted
Mar 21, 2025
Start date
Apr 1, 2025 (estimated)
Primary completion
Apr 15, 2025 (estimated)
Completion
Apr 30, 2025 (estimated)
Last update
Mar 21, 2025

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion