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Esophageal CancerPhase 2SORTNCT07162506

dCRT vs. Surgery in Resectable ESCC Patients Achieving cCR/PR After Induction Chemoimmunotherapy

A Phase 2 study testing Surgery, Radiotherapy and Chemotherapy in people with Esophageal Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This study is evaluating two treatment approaches for patients with locally advanced, resectable esophageal squamous cell carcinoma (ESCC) who have a good response to 2-3 cycles of induction chemoimmunotherapy. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Esophageal Cancer
What is being tested?
Surgery, Radiotherapy and Chemotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteChina
Study dates
3 Nov 2025to 30 Aug 2030
Phase
Phase 2
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Volunteered to participate, cooperated with follow-up visits.
  • Aged 18 - 75 years (inclusive), male or female.
  • Histologically confirmed, resectable locally advanced ESCC, defined as cT1N1-3M0 or cT2-4aN0-3M0 according to the AJCC 8th edition, with cCR or PR achieved after 2-3 cycles of induction chemoimmunotherapy consisting of a permitted PD-1 inhibitor combined with a taxane and a platinum agent.
  • Presence of measurable and/or non-measurable lesions as defined by Japanese Classification of Esophageal Cancer (12th Edition);
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
  • Life expectancy ≥ 3 months.
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  • The function of major organs meets the following requirements:
  • Absolute neutrophil count (ANC) ≥ 1.5×10^9/L;
  • Platelets ≥ 80×10^9/L;
  • Hemoglobin ≥ 9 g/dL;
  • Serum albumin ≥ 2.8 g/dL;
  • Total bilirubin ≤ 1.5 × ULN, ALT, AST and/or ALP ≤ 2.5 × ULN;
  • Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 60 mL/min;
  • International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5× ULN (subjects on stable doses of anticoagulation therapy, such as low molecular weight heparin or warfarin, and with INR within the expected therapeutic range of the anticoagulant can be screened);
  • Comprehensive baseline staging evaluation prior to induction chemoimmunotherapy, including esophagogastroduodenoscopy with biopsy and/or EUS, contrast-enhanced CT of the neck, chest, and upper abdomen, MRI in patients without contraindications, and an upper gastrointestinal contrast study. PET/CT may be performed when clinically indicated and feasible.
  • Patients of childbearing potential must use a medically approved contraceptive method (such as intrauterine device, contraceptive pills, or condoms) during the study treatment period and within 6 months after the end of the study treatment; serum Human Chorionic Gonadotropin (HCG) or urine HCG test must be negative within 72 hours before study enrollment; and must not be breastfeeding.

Who cannot join

  • Prior surgery for esophageal cancer;
  • Esophageal fistulae due to infiltration of the primary tumor；
  • Risk of gastrointestinal bleeding, esophageal fistula or esophageal perforation;
  • Poor nutritional status, weight loss of ≥10% in the previous 2 months, with no significant improvement after nutritional intervention;
  • Major surgery or severe trauma within 4 weeks before formal enrollment;
  • Uncontrollable pleural effusion, pericardial effusion, or ascites that requires repeated drainage;
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  • Received or receiving any of the following treatments in the past:
  • Radiotherapy or targeted therapy;
  • Participation in a study of an investigational agent or device within 4 weeks before the first dose of study treatment;
  • Use of systemic corticosteroids at a dose >10 mg/day prednisone equivalent or other systemic immunosuppressive therapy within 2 weeks before formal enrollment, except for inhaled or topical corticosteroids, physiologic hormone-replacement therapy, and short-term corticosteroids used for prophylaxis or treatment of allergic reactions, nausea, or vomiting;
  • Receipt of a live vaccine or antitumor vaccine within 4 weeks before formal enrollment;
  • Any active autoimmune disease or history of autoimmune disease (e.g., interstitial pneumonitis, uveitis, enteritis, hepatitis, pituitary gland inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism); Except for patients with vitiligo or those who had asthma or allergies in childhood but did not need any intervention as adults; patients with autoimmune-mediated hypothyroidism treated with stable doses of thyroid replacement hormone and type I diabetes mellitus treated with stable doses of insulin may be included;
  • Diagnosis of immunodeficiency, including positive HIV test, other acquired/congenital immunodeficiency diseases, organ transplantation and allogeneic bone marrow transplantation;
  • Diagnosis of uncontrolled cardiac clinical symptoms or disease such as: a. NYHA II or above heart failure; b. unstable angina; c. myocardial infarction within 1 year; d. clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention;
  • Severe infections (CTCAE > grade 2), such as severe pneumonia requiring hospitalisation, bacteraemia, infectious co-morbidities, etc., within 4 weeks before formal enrollment; Baseline chest imaging suggestive of active lung inflammation, signs and symptoms of infection requiring oral or intravenous antibiotic treatment within 2 weeks before the first use of study treatment, except for prophylactic antibiotic use;
  • History of interstitial lung disease or non-infectious pneumonia, or pulmonary insufficiency ≥ grade 3 as confirmed by pulmonary function tests;
  • Active tuberculosis infection detected by history or CT examination, or history of active tuberculosis infection within 1 year before enrollment or more than 1 year previously without regular treatment;
  • Active hepatitis B infection (HBV DNA >2000 IU/mL) or active hepatitis C infection with detectable HCV RNA;
  • Presence of abnormal sodium, potassium, and calcium laboratory test values greater than grade 1 within 2 weeks prior to enrollment that do not improve with treatment;
  • Known hypersensitivity or contraindication to camrelizumab, nab-paclitaxel, carboplatin, or any component of the protocol-defined study treatments;
  • Previously diagnosed with any other malignancy within 5 years before the first use of the investigational drug, except for malignancies with low risk of metastasis and death (5-year survival rate>90%), such as adequately treated basal cell or squamous cell skin cancer or cervical carcinoma in situ.
  • As judged by the investigator, the subject has other factors that may lead to forced termination of the study midway.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Wencheng Zhang, M.D. contact

02223340123 ext. 1121

zhangwencheng@tjmuch.com

China1 site, 1 recruiting

  • Tianjin Cancer Hospital

    Tianjin, Tianjin Municipality

    Wencheng Zhang, M.D., 02223340123 ext. 1121, zhangwencheng@tjmuch.com

    Recruiting

Other trials in China

About this study

Official title: Surgery or Definitive Chemoradiotherapy in Patients With Locally Advanced Resectable Esophageal Squamous Cell Carcinoma Achieving Clinical Response After Neoadjuvant Chemoimmunotherapy: A Prospective, Preference-Based, Comparative Two-Cohort Phase II Trial (SORT Trial)

This study is evaluating two treatment approaches for patients with locally advanced, resectable esophageal squamous cell carcinoma (ESCC) who have a good response to 2-3 cycles of induction chemoimmunotherapy. Patients who achieve either a clinical complete response (cCR) or partial response (PR) will be eligible to join the study.

After enrollment, patients will choose, together with their doctors, between surgery and definitive chemoradiotherapy (dCRT). Patients in the surgery group will undergo esophagectomy with lymph-node dissection. Patients in the dCRT group will receive radiotherapy together with chemotherapy. After surgery or dCRT, all patients will receive camrelizumab immunotherapy for up to 12 months if they have recovered sufficiently and have no evidence of disease progression.

The study will compare the effectiveness and safety of these two treatment approaches and will assess whether dCRT can provide an organ-preserving treatment option for selected patients. The study will enroll approximately 120 patients.

Being tested
Surgery, Radiotherapy, Chemotherapy, Immunotherapy
Medical subject headings
Esophageal Neoplasms

What participants receive

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

  • SurgeryProcedure or surgery

    Esophagectomy with systematic lymphadenectomy.

  • RadiotherapyRadiation

    Radiotherapy: 50.4 Gy/28f

  • ChemotherapyDrug

    Chemotherapy: nab-paclitaxel 175mg/m² + carboplatin AUC=5, q21d for 2 cycles

  • ImmunotherapyDrug

    Camrelizumab consolidation therapy (200mg q21d) up to 1 year.

Study groups in NCT07162506
Study groupRoleWhat they receive
Surgery CohortActive comparatorEsophagectomy with systematic lymphadenectomy.
Receives: Procedure: Surgery; Drug: Immunotherapy
dCRT CohortExperimentalDefinitive concurrent chemoradiotherapy (radiotherapy: 50.4 Gy/28f; chemotherapy: nab-paclitaxel 175mg/m² + carboplatin AUC=5, q21d for 2 cycles)
Receives: Radiation: Radiotherapy; Drug: Chemotherapy; Drug: Immunotherapy

What is being measured

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

  1. DFS

    Disease-Free Survival

    Measured: up to 3 years

Secondary outcomes (7)

  1. OS

    Overall Survival

    Measured: up to 3 years

  2. LRR

    locoregional disease recurrence

    Measured: up to 3 years

  3. R0 resection

    Surgical and pathological outcome

    Measured: up to 3 years

  4. AEs

    Adverse Events

    Measured: up to 3 years

  5. QoL

    Quality of Life score

    Measured: up to 3 years

  6. PG - SGA

    Patient - Generated Subjective Global Assessment Scale

    Measured: up to 3 years

  7. SSA

    Standardized Swallowing Assessment

    Measured: up to 3 years

Timeline

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

  1. First posted9 Sep 2025
  2. Study start3 Nov 2025
  3. Primary completion30 Aug 2027 (estimated)
  4. Study completion30 Aug 2030 (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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07162506
Sponsor's protocol ID
E20260592
Acronym
SORT
Status last verified
May 2026
First submitted
1 Sep 2025
Last updated
15 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Surgery, Radiotherapy and Chemotherapy in people with Esophageal Cancer, run by Tianjin Medical University Cancer Institute and Hospital 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 16 inclusion and 22 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: looking for participants now, as of the sponsor's last update on 15 Oct 2026. 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?

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 Wencheng Zhang, M.D. (02223340123 ext. 1121, zhangwencheng@tjmuch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

DFS (time frame: up to 3 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 NCT07162506.

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 Oct 2026.

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