AzTrials
AzTrials

Esophageal CancerEarly Phase 1NCT07371247

Based on ctDNA-MRD Guided Adjuvant Treatment Escalation After Definitive Chemoradiotherapy for Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma: a Study on Safety and Efficacy

A Early Phase 1 study testing Step-up therapy and Standard treatment Routine treatment in people with Esophageal Cancer and MRD, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
Search all trials

Trial summary

Numerous studies have confirmed that ctDNA-MRD detection technology based on peripheral blood can identify minimal residual disease (MRD) following surgery and other curative treatments, indicating a higher risk of recurrence. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Esophageal Cancer, MRD, ctDNA
What is being tested?
Step-up therapy and Standard treatment Routine treatment
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
65 participants
Where
1 siteChina
Study dates
20 Dec 2025to 30 Nov 2027
Phase
Early Phase 1
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed locally advanced esophageal squamous cell carcinoma (ESCC), with clinical stage Ⅱ-Ⅳ unresectable disease (including unresectable cases, patients with surgical contraindications, or those who refuse surgery). According to the 8th edition AJCC staging system, the pretreatment clinical stage is defined as: cT1N2-3M0, cT2-4bN0-3M0; M1 disease is limited to non-regional lymph node metastases, excluding distant organ metastases.
  • No prior systemic therapy administered for the disease, and planned to receive definitive chemoradiotherapy (dCRT).
  • Having undergone 1021-gene large panel testing on tissue samples.
  • Aged 18-80 years old.
  • Expected overall survival ≥ 6 months.
  • ECOG performance status 0-1.
Show all 9Show fewer
  • Normal blood biochemical parameters, with normal liver and kidney function.
  • Able to understand the study protocol, voluntarily participate in the study, and sign the informed consent form.
  • Good compliance, able to cooperate with specimen collection at all designated time points and provide relevant clinical data.

Who cannot join

  • Have participated in other clinical trials within 3 months prior to enrollment.
  • Have a history of other malignant tumors within 3 years prior to the diagnosis of esophageal cancer.
  • Have a history of severe mental illness.
  • Patients who are unable to understand the study protocol and thus cannot cooperate, or who refuse to sign the informed consent form.
  • Have contraindications to chemoradiotherapy.
  • Have a history of autoimmune diseases.

Trial locations and contacts

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

China1 site

  • Jiangsu Province Hospital

    Nanjing, Jiangsu

Other trials in China

About this study

Numerous studies have confirmed that ctDNA-MRD detection technology based on peripheral blood can identify minimal residual disease (MRD) following surgery and other curative treatments, indicating a higher risk of recurrence. Multiple exploratory studies in esophageal cancer have demonstrated that patients who are ctDNA-MRD positive after definitive chemoradiotherapy (dCRT) exhibit poorer progression-free survival (PFS) and a higher risk of recurrence. Furthermore, the recent NEXUS-1 translational study confirmed that 66.7% of unresectable patients achieved the goal of conversion surgery after receiving definitive chemoradiotherapy combined with immunotherapy. Notably, patients who were ctDNA-MRD positive after chemoradiotherapy had a significantly worse prognosis. These findings suggest that ctDNA-MRD status after chemoradiotherapy has prognostic stratification value and that consolidative immunotherapy is effective.

Based on these previous discoveries, this study aims to investigate the safety and efficacy of an escalated treatment strategy involving immunotherapy combined with chemotherapy for high-risk populations after definitive chemoradiotherapy for esophageal cancer, guided by personalized MRD detection results.

Being tested
Step-up therapy, Standard treatment Routine treatment
Medical subject headings
Esophageal Neoplasms

What participants receive

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

  • Step-up therapyDrug

    Patients receive step-up therapy, consisting of 4 cycles of immunotherapy combined with intravenous chemotherapy, followed by immunotherapy plus oral chemotherapy for 6 months. MRD testing is repeated after the completion of immunotherapy combined with intravenous chemotherapy.

  • Standard treatment Routine treatmentDrug

    Patients receive 2 cycles of consolidative intravenous chemotherapy and then proceed to routine follow-up. MRD testing is repeated after the completion of chemotherapy.

Study groups in NCT07371247
Study groupRoleWhat they receive
MRD-positive groupsActive comparatorAssessed as MRD-positive based on ctDNA testing
Receives: Drug: Step-up therapy
MRD-negative groupsSham comparatorAssessed as MRD-negative based on ctDNA testing
Receives: Drug: Standard treatment Routine treatment

What is being measured

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

  1. PFS

    Measured: 1 year after enrollment

Timeline

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

  1. First posted27 Jan 2026
  2. Study start20 Dec 2025
  3. Primary completion31 Oct 2027 (estimated)
  4. Study completion30 Nov 2027 (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
Early Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
65 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07371247
Sponsor's protocol ID
2025-SR-1071
Status last verified
Dec 2025
First submitted
19 Jan 2026
Last updated
27 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Chen B, Liu S, Zhu Y, Wang R, Cheng X, Chen B, Dragomir MP, Zhang Y, Hu Y, Liu M, Li Q, Yang H, Xi M. Predictive role of ctDNA in esophageal squamous cell carcinoma receiving definitive chemoradiotherapy combined with toripalimab. Nat Commun. 2024 Mar 1;15(1):1919. doi: 10.1038/s41467-024-46307-7.

    PubMed 38429311

  • Takei S, Kotani D, Laliotis G, Sato K, Fujiwara N, Kawazoe A, Hashimoto T, Mishima S, Nakayama I, Nakamura Y, Bando H, Kuboki Y, Sakashita S, Spickard E, George GV, Dutta P, Sharma S, Malhotra M, Sethi H, Jurdi A, Liu MC, Yoshino T, Shitara K, Kojima T, Fujita T. Circulating Tumor DNA Assessment to Predict Risk of Recurrence After Surgery in Patients With Locally Advanced Esophageal Squamous Cell Carcinoma: A Prospective Observational Study. Ann Surg. 2026 Aug 1;284(2):321-327. doi: 10.1097/SLA.0000000000006699. Epub 2025 Mar 21.

    PubMed 40115982

  • Liu Z, Wang G, Yang Y, Su Y, Zhang H, Liu J, Cui P, Fan X, Yang J, Zhang Z, Gao X, Chao Y, Mostert B, van Lanschot JJB, Wijnhoven BPL, Law S, Li C, Cai S, Li Z. ctDNA detects residual disease after neoadjuvant chemoradiotherapy and guides adjuvant therapy in esophageal squamous cell carcinoma. Cell Rep Med. 2025 Sep 16;6(9):102334. doi: 10.1016/j.xcrm.2025.102334. Epub 2025 Sep 5.

    PubMed 40914168

  • Driessen RS, van Diemen PA, Raijmakers PG, Knuuti J, Maaniitty T, Underwood SR, Nagel E, Robbers LFHJ, Demirkiran A, von Bartheld MB, van de Ven PM, Hofstra L, Somsen GA, Tulevski II, Boellaard R, van Rossum AC, Danad I, Knaapen P. Functional stress imaging to predict abnormal coronary fractional flow reserve: the PACIFIC 2 study. Eur Heart J. 2022 Sep 1;43(33):3118-3128. doi: 10.1093/eurheartj/ehac286.

    PubMed 35708168

  • Zhu Y, Wen J, Li Q, Chen B, Zhao L, Liu S, Yang Y, Wang S, Lv Y, Li J, Zhang L, Hu Y, Liu M, Xi M. Toripalimab combined with definitive chemoradiotherapy in locally advanced oesophageal squamous cell carcinoma (EC-CRT-001): a single-arm, phase 2 trial. Lancet Oncol. 2023 Apr;24(4):371-382. doi: 10.1016/S1470-2045(23)00060-8.

    PubMed 36990609

  • Ajani JA, D'Amico TA, Almhanna K, Bentrem DJ, Besh S, Chao J, Das P, Denlinger C, Fanta P, Fuchs CS, Gerdes H, Glasgow RE, Hayman JA, Hochwald S, Hofstetter WL, Ilson DH, Jaroszewski D, Jasperson K, Keswani RN, Kleinberg LR, Korn WM, Leong S, Lockhart AC, Mulcahy MF, Orringer MB, Posey JA, Poultsides GA, Sasson AR, Scott WJ, Strong VE, Varghese TK Jr, Washington MK, Willett CG, Wright CD, Zelman D, McMillian N, Sundar H; National comprehensive cancer network. Esophageal and esophagogastric junction cancers, version 1.2015. J Natl Compr Canc Netw. 2015 Feb;13(2):194-227. doi: 10.6004/jnccn.2015.0028.

    PubMed 25691612

  • Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.

    PubMed 33538338

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Step-up therapy and Standard treatment Routine treatment in people with Esophageal Cancer and MRD, run by The First Affiliated Hospital with Nanjing Medical University 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 9 inclusion and 6 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: enrolling by invitation, as of the sponsor's last update on 27 Jan 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. Some participants in this study may receive a placebo. 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PFS (time frame: 1 year after enrollment). 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 NCT07371247, which also lists 7 linked publications.

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 27 Jan 2026.

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