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Esophageal Squamous Cell Carcinoma (ESCC)NCT07067450

Adjuvant Immunotherapy for Esophageal Squamous Cell Carcinoma

A study testing Immune Checkpoint Inhibitors ( pembrolizumab, tislelizumab, sintilimab, camrelizumab, and toripalimab) and Observation in people with Esophageal Squamous Cell Carcinoma (ESCC), run by Sichuan University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

Patients with esophageal cancer still face a high risk of recurrence after receiving neoadjuvant chemoradiotherapy (nCRT) combined with radical surgery, especially for those who do not achieve pathological complete response (non-pCR). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Immune Checkpoint Inhibitors ( pembrolizumab, tislelizumab, sintilimab, camrelizumab, and toripalimab) and Observation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
98 participants
Where
No sites listed yet
Study dates
20 Jul 2025to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged ≥18 years.
  • Histologically confirmed esophageal squamous cell carcinoma.
  • Preoperative staging of cT1b-cT2N+M0 or cT3-cT4a, any N, M0 (UICC/AJCC TNM staging, 8th edition, 2017), and treated with neoadjuvant therapy using an immunotherapy combined with a taxane and platinum regimen, followed by radical surgical resection.
  • R0 resection.
  • Postoperative pathological staging of ≥ypT1 and/or ≥ypN1.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤1.
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  • Physical examination and imaging studies completed within 4 weeks prior to randomization confirming disease-free status, with imaging studies including CT scans of the chest and abdomen.
  • Normal function of major organs.
  • Women of childbearing potential and men with partners of childbearing potential must agree to use effective contraception during the treatment period and for 6 months before and after the treatment period.
  • Willingness of the subject to participate in the study and provision of informed consent.
  • Good compliance of the subject, with the ability to follow up on efficacy and adverse events/reactions as required by the study plan.

Who cannot join

  • Presence of blood-borne infectious disease human immunodeficiency virus (HIV).
  • Presence of psychiatric disorders.
  • History of any other malignancy within the past 5 years (except for completely cured cervical carcinoma in situ or basal cell or squamous cell carcinoma of the skin).
  • Treatment in the ICU due to severe complications after radical surgery for esophageal cancer.
  • Severe anastomotic stricture after surgery, requiring dilation treatment.
  • Known severe allergy to any component of the study drug.
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  • Presence of other autoimmune diseases, or long-term systemic use of immunosuppressants or corticosteroids; the use of inhaled or topical corticosteroids or equivalent doses of adrenal corticosteroid replacement therapy is permitted.
  • Active hepatitis B (HBV-DNA ≥ 2000 IU/mL or 10⁴ copies/mL), hepatitis C (positive hepatitis C antibody, and HCV-RNA above the lower limit of detection of the assay). Patients with a hepatitis B copy number ≤ 10³ copies/mL after anti-hepatitis B or C treatment may be considered for enrollment at the discretion of the principal investigator.
  • Presence of any unstable systemic disease (including active uncontrolled peptic ulcer, active infection, grade 4 hypertension, unstable angina, congestive heart failure, unstable cerebrovascular disease, thromboembolic disease, hepatic, renal, metabolic diseases, or unhealed fractures, wounds as judged by the surgeon).
  • Patients who are difficult to communicate with or follow up with over the long term.
  • Women who are breastfeeding.
  • Currently participating or planning to participate in other clinical trials.
  • Other situations deemed unsuitable by the physician.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Qing Li, PhD contact

+8618702848178

liqing@scu.edu.cn

About this study

Official title: Adjuvant Immunotherapy Versus Observation Following Neoadjuvant Chemoimmunotherapy for Esophageal Squamous Cell Carcinoma: A Randomized Controlled Trial

Patients with esophageal cancer still face a high risk of recurrence after receiving neoadjuvant chemoradiotherapy (nCRT) combined with radical surgery, especially for those who do not achieve pathological complete response (non-pCR). Compared with the overall non-pCR population, the subgroup with lymph node positivity has a significantly worse prognosis. The CheckMate 577 study confirmed that in patients with locally advanced resectable esophageal cancer or esophageal-gastric junction cancer, adjuvant treatment with nivolumab after nCRT significantly prolonged disease-free survival compared with placebo (median DFS: 22.4 months vs 11.0 months; HR=0.69, p<0.001).

The current research focus has expanded to the field of neoadjuvant chemoimmunotherapy, but the adjuvant treatment strategy after such therapy remains a blank slate. Given that esophageal squamous cell carcinoma (ESCC) is the predominant type of esophageal cancer in our country, it is of great clinical significance to explore adjuvant treatment strategies after neoadjuvant chemoimmunotherapy combined with radical resection.

Based on the above background, we have designed a randomized controlled trial (RCT) to evaluate the efficacy of adjuvant immunotherapy versus observation alone in patients with ESCC after neoadjuvant chemoimmunotherapy, with the hope of providing evidence-based medical evidence for this population.

Being tested
Immune Checkpoint Inhibitors ( pembrolizumab, tislelizumab, sintilimab, camrelizumab, and toripalimab), Observation
Keywords
esophageal squamous cell carcinoma, neoadjuvant chemoimmunotherapy, Adjuvant immunotherapy
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.

  • Immune Checkpoint Inhibitors ( pembrolizumab, tislelizumab, sintilimab, camrelizumab, and toripalimab)Drug

    The immune checkpoint inhibitors used for adjuvant therapy after surgery were consistent with those used during the neoadjuvant treatment before surgery, including pembrolizumab, tislelizumab, sintilimab, camrelizumab, and toripalimab.

  • ObservationOther

    Postoperative observation is conducted without the use of any anti-tumor treatment.

Study groups in NCT07067450
Study groupRoleWhat they receive
Adjuvant Immunotherapy GroupExperimentalFor patients with non-pCR esophageal squamous cell carcinoma after neoadjuvant chemoimmunotherapy, adjuvant immunotherapy with immune checkpoint inhibitors (the same ICIs used before surgery) is administered postoperatively, once every three weeks, for a total of 15 treatments.
Receives: Drug: Immune Checkpoint Inhibitors ( pembrolizumab, tislelizumab, sintilimab, camrelizumab, and toripalimab)
Observation GroupActive comparatorFor patients with non-pCR esophageal squamous cell carcinoma after neoadjuvant chemoimmunotherapy, postoperative observation is conducted without the use of any anti-tumor treatment.
Receives: Other: Observation

What is being measured

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

  1. Disease-Free Survival (DFS)

    In this study, disease-free survival (DFS) refers to the time from the start of surgery to the first occurrence of disease recurrence or metastasis. If a patient does not experience disease recurrence or metastasis during the follow-up period, their DFS is typically recorded as the time from the start of treatment to the end of follow-up.

    Measured: From the time of patient enrollment, up to a maximum of 2 years.

Secondary outcomes (1)

  1. Overall Survival (OS)

    Overall Survival (OS) refers to the time from the start of enrollment to the time of death from any cause. If a patient is still alive at the end of the study, their OS is recorded as the time from the start of the study to the end of the study.

    Measured: From the time of patient enrollment, up to a maximum of 5 years.

Timeline

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

  1. First posted16 Jul 2025
  2. Study start20 Jul 2025 (estimated)
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
98 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07067450
Sponsor's protocol ID
AI-ESCC
Status last verified
Jul 2025
First submitted
4 Jul 2025
Last updated
16 Jul 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Immune Checkpoint Inhibitors ( pembrolizumab, tislelizumab, sintilimab, camrelizumab, and toripalimab) and Observation in people with Esophageal Squamous Cell Carcinoma (ESCC), run by Sichuan University.

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 13 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: opening soon, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

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.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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

Contact Qing Li, PhD (+8618702848178, liqing@scu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease-Free Survival (DFS) (time frame: From the time of patient enrollment, up to a maximum of 2 years.). 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 NCT07067450.

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 16 Jul 2025.

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