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AzTrials

Locally Advanced Esophageal Squamous Cell CarcinomaPhase 2NCT06342167

Efficacy and Safety of Concurrent PD-1 Inhibitor and Radiotherapy With Immunonutrition for Esophageal Squamous Cell Carcinoma

A Phase 2 study testing Radiotherapy, Programmed Cell Death Protein 1 Inhibitor and Immunonutrition support in people with Locally Advanced Esophageal Squamous Cell Carcinoma and Sintilimab, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 10 sites 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

At present, concurrent chemoradiotherapy (cCRT) with platin-based dual-drug regimen is the standard treatment for inoperable, locally advanced esophageal cancer in patients with a good performance status. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Radiotherapy, Programmed Cell Death Protein 1 Inhibitor and Immunonutrition support
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
57 participants
Where
10 sitesChina
Study dates
14 Mar 2024to 1 Dec 2026
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged 18 years or order.
  • Diagnosed with locally advanced or early stage esophageal squamous cell carcinoma by pathological examinations of the primary lesion and imaging examinations, which are not resectable.
  • Confirmed to be unresectable and unable to tolerate synchronous chemoradiotherapy by multidisciplinary consultation, and has not undergone systemic drug therapy in the past.
  • PD-L1 tumor proportion score or combined positive score of ≥1%.
  • At least one measurable lesion on imaging according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
  • An Eastern Cooperative Oncology Group (ECOG) performance status score of 0 -2.
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  • Expected survival time of more than three months.
  • Adequate organ function defined as the following laboratory indicators:
  • Absolute neutrophil count (ANC) ≥ 1.5×109/L without use of granulocyte colony-stimulating factor in the past 14 days.
  • Platelet count ≥ 100×109/L without blood transfusion in the past 14 days.
  • Hemoglobin > 9g/dL without blood transfusion or use of erythropoietin-stimulating agents in the past 14 days.
  • Total bilirubin ≤ 1.5×upper limit of normal (ULN).
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5×ULN.
  • Creatinine ≤ 1.5×ULN and creatinine clearance calculated using the Cockcroft-Gault formula) ≥ 60 ml/min.
  • Good coagulation function, defined as an international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5×ULN.
  • Normal thyroid function, defined as thyroid-stimulating hormone (TSH) within the normal range. If the baseline TSH is outside the normal range, subjects with total T3 (or FT3) and FT4 within the normal range can still be included.
  • Normal cardiac enzyme spectrum (or clinically insignificant laboratory abnormalities as determined by the investigator)
  • Negative pregnancy test (urine or serum) within 3 days before the first dose of study drug for female subjects of childbearing potential. If the urine pregnancy test cannot be confirmed as negative, a blood pregnancy test is required. Non-childbearing potential female is defined as postmenopausal for at least 1 year or has undergone surgical sterilization or hysterectomy.
  • Willing to sign the informed consent form.

Who cannot join

  • Subjects with any of the following conditions cannot participate in the study:
  • A high risk of bleeding or perforation due to clear invasion of adjacent organs (large arteries or trachea) by the tumor, or with fistula.
  • Diagnosed with malignancies other than esophageal cancer within 3 years prior to the first dose (excluding cured basal cell carcinoma or squamous cell carcinoma of the skin and/or radically resected carcinoma in situ).
  • Previous immunological or immunomodulatory drugs as systemic whole-body treatment, including thymic peptides, interferon, interleukins, except for local use to control pleural effusion.
  • Previous chest radiotherapy.
  • A history of allogeneic organ transplantation (except for corneal transplantation) or allogeneic hematopoietic stem cell transplantation.
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  • Allergic to the study drug, Sintilimab, or its excipients.
  • A history of human immunodeficiency virus (HIV) infection (i.e., HIV1/2 antibody positive).
  • Untreated active hepatitis B defined as HBsAg positive and HBV-DNA copy number greater than the upper limit of the normal value in the laboratory of the study center.
  • Note: Patients with hepatitis B who meet the following criteria can also be included:
  • HBV viral load <1000 copies/ml (200IU/ml) before the first dose; the patient should receive anti-HBV treatment throughout chemotherapy in the entire study to avoid viral reactivation.
  • For patients who are anti-HBc (+), HBsAg (-), anti-HBs (-), and HBV viral load (-), no prophylactic anti-HBV treatment is required, but close monitoring of viral reactivation is needed.
  • Active hepatitis C virus (HCV) infection defined as HCV antibody positive and HCV-RNA levels higher than the detection limit.
  • Having received live vaccines within 30 days prior to the first dose (Cycle 1, Day 1).
  • Note: It is allowed to receive inactivated virus vaccines for seasonal influenza within 30 days prior to the first dose, but attenuated live influenza vaccines administered intranasally are not allowed.
  • Pregnant or lactating women;
  • Any serious or uncontrollable systemic diseases, such as:
  • Significant and symptomatic abnormalities in rhythm, conduction or morphology on resting electrocardiogram, such as complete left bundle branch block, second-degree or higher heart block, ventricular arrhythmia, or atrial fibrillation;
  • Unstable angina, congestive heart failure, or chronic heart failure classified as New York Heart Association (NYHA) class ≥ 2;
  • Any arterial thrombosis, embolism or ischemic events, such as myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack, occurring within 6 months prior to enrollment;
  • Poor blood pressure control defined as systolic blood pressure > 140 mmHg and/or diastolic blood pressure > 90 mmHg;
  • A history of non-infectious pneumonia requiring glucocorticoid therapy within 1 year prior to initial treatment, or current clinical activity of interstitial lung disease;
  • Active pulmonary tuberculosis;
  • Active or uncontrolled infections requiring systemic therapy;
  • Active diverticulitis, abdominal abscess, or gastrointestinal obstruction;
  • Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis;
  • Poorly controlled diabetes (fasting blood glucose (FBG) > 10mmol/L);
  • Urine protein ≥ ++ on routine urinalysis, with confirmed 24-hour urine protein quantification > 1.0 g;
  • Psychiatric disorders that are unable to comply with treatment.
  • Any other medical histories, disease evidence, treatment, or laboratory values that may interfere with the test results, hinder the full participation in the study, or other situations that the investigator deems unsuitable for inclusion due to potential risks.

Trial locations and contacts

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

Jianyang Wang, MD contact

+86-13810095191

pkucell@163.com

10 sites in 1 country

China10 sites, 10 recruiting

  • Department 1st of Radiation Oncology, Anyang Tumor Hospital

    Anyang, Henan

    Xiaomin Wang, MD, shine828@163.com

    Zhiyong Zheng, MD

    Recruiting

  • Department of Radiation Oncology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College

    Beijing, Beijing Municipality, 100021

    Jianyang Wang, MD, +86-13810095191, pkucell@163.com

    Recruiting

  • Department of Radiation Oncology，Fei County People's Hospital

    Feixian, Shandong

    Xia Wu, MD, 529385356@qq.com

    Recruiting

  • Department of Radiation Oncology，Clinical Oncology School of Fujian Medical University，Fujian Cancer Hospital

    Fujian, Fujian

    Yuanji Xu, MD, xuyuanji@fjmu.edu.cn

    Recruiting

  • Department of Oncology, Affiliated Hospital, Hebei University of Engineering

    Handan, Hebei

    Qing Qi, MD, qiqing365@163.com

    Recruiting

  • Department of Radiation Oncology, Affiliated hospital of Jining Medical University

    Jining, Shandong

    Qin Du, MD, ppd1982@163.com

    Recruiting

  • Taizhou hospital of Wenzhou Medical University

    Taizhou, Zhejiang, 317000

    Haihua Yang, MD, yhh93181@hotmail.com

    Recruiting

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, Tianjin Municipality, 300060

    Liming Xu, xlm19821223@126.com

    Recruiting

  • Department of Radiation Oncology the first affiliated hospital of Xinxiang Medical University

    Xinxiang, Henan

    Meiling Chen, MD, cengjingcml@163.com

    Recruiting

  • Department of Radiation Oncology, General Hospital of Ningxia Medical University

    Yinchuan, Ningxia

    Wenyan Pan, MD, lovelypenguin1023@163.com

    Recruiting

Other trials in China

About this study

Official title: Efficacy and Safety of Concurrent Sintilimab and Radiotherapy With Immunonutrition Support in Esophageal Cancer: A Phase II Multicenter Clinical Trial

At present, concurrent chemoradiotherapy (cCRT) with platin-based dual-drug regimen is the standard treatment for inoperable, locally advanced esophageal cancer in patients with a good performance status. However, cCRT has substantial toxic effects, and a large number of patients with older age, malnutrition and other morbidities, cannot tolerate cCRT. Several phase II trials showed combining PD-1 inhibitor with definitive cCRT provided encouraging activity and acceptable toxicity in patients with locally advanced esophageal squamous cell carcinoma (LA-ESCC).

Therefore, this single-arm, multicenter, phase II trial aims to assess the efficacy and safety of immunotherapy plus radiotherapy with immunonutrition support in patients with LA-ESCC and positive PD-L1 expression who are intolerant to cCRT.

Read the detailed description

This single-arm trial is designed to evaluate the efficacy and safety of concurrent immunotherapy (sintilimab) plus radiotherapy with immunonutrition support (enteral nutritional emulsion (TPF-T) followed by consolidation immunotherapy in inoperable patients with locally advanced or early stage esophageal squamous cell carcinoma , who are PD-L1 positive expression and intolerant to cCRT. The eligible patients will receive concurrent treatment consisting of total dose of 50-60 Gy in 25-30 fractions and 200 mg of sintilimab administered every three weeks, along with enteral nutritional emulsion (TPF-T) support (600-1600 ml per day according to the nutrition status evaluation). The primary outcome is 1-year progression-free survival (PFS) rate. The investigators hypothesized PD-L1 inhibitor plus radiotherapy will improve the 1-year PFS from 40% to 60%. Then, 58 patients will be needed in total. The secondary outcomes will include objective response rate (ORR), overall survival (OS), progression-free and overall survival, and incidence of adverse events.

This study is approval by the National GCP Center for Anticancer Drugs, Independent Ethics Committee, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Science and Peking Union Medical College (Study ID: 24/074-4354).

Being tested
Radiotherapy, Programmed Cell Death Protein 1 Inhibitor, Immunonutrition support

What participants receive

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

  • RadiotherapyRadiation

    Interventions consist of 50-60 Gy in 25-30 fractions of radiotherapy.

  • Programmed Cell Death Protein 1 InhibitorDrug

    Also called PD-1 Inhibitor

    200 mg of Sintilimab administered every three weeks concurrently with radiotherapy and after radiotherapy as consolidation therapy up to 1year.

  • Immunonutrition supportDietary supplement

    Also called enteral nutritional emulsion

    600-1600 ml of TPF-T per day according to the nutrition status evaluation

Study groups in NCT06342167
Study groupRoleWhat they receive
Concurrent immunotherapy and radiotherapyExperimentalSintilimab + radiotherapy + enteral nutritional emulsion (TPF-T)
Receives: Radiation: Radiotherapy; Drug: Programmed Cell Death Protein 1 Inhibitor; Dietary Supplement: Immunonutrition support

What is being measured

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

  1. 1-year Progression-free survival rate (PFS)

    Progression-free survival rate is defined the rate of progress event at 1-years after radiotherapy. Progression event is defined as event of primary tumor and regional recurrence, or distant metastasis

    Measured: From start of treatment until 1 years of follow-up.

Secondary outcomes (5)

  1. Objective response rate

    Response is defined by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

    Measured: Measured at 3 months after completion of radiotherapy

  2. Progression-free survival

    Progression-free survival is defined as the time from treatment to the event of primary tumor and regional recurrence, or distant metastasis

    Measured: Measured at months 6, 12, 18, and 24.

  3. Overall survival rate

    Live rate at months 6, 12, 18, and 24.

    Measured: Measured at months 6, 12, 18, and 24.

  4. Overall survival

    Live status at different time points.

    Measured: From start of treatment until 3 years of follow-up.

  5. Incidence of adverse events

    Adverse events are classified according to the Common Terminology Criteria for Adverse Events (CTCAE 5.0) criteria.

    Measured: Measured at months 6, 12, 18, and 24.

Timeline

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

  1. First posted2 Apr 2024
  2. Study start14 Mar 2024
  3. Primary completion1 Dec 2026 (estimated)
  4. Study completion1 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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
57 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06342167
Sponsor's protocol ID
NCC4409
Status last verified
Oct 2026
First submitted
26 Mar 2024
Last updated
7 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Park S, Oh D, Choi YL, Chi SA, Kim K, Ahn MJ, Sun JM. Durvalumab and tremelimumab with definitive chemoradiotherapy for locally advanced esophageal squamous cell carcinoma. Cancer. 2022 Jun 1;128(11):2148-2158. doi: 10.1002/cncr.34176. Epub 2022 Mar 23.

    PubMed 35319779

  • 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

  • Tachihara M, Tsujino K, Ishihara T, Hayashi H, Sato Y, Kurata T, Sugawara S, Shiraishi Y, Teraoka S, Azuma K, Daga H, Yamaguchi M, Kodaira T, Satouchi M, Shimokawa M, Yamamoto N, Nakagawa K; West Japan Oncology Group (WJOG). Durvalumab Plus Concurrent Radiotherapy for Treatment of Locally Advanced Non-Small Cell Lung Cancer: The DOLPHIN Phase 2 Nonrandomized Controlled Trial. JAMA Oncol. 2023 Nov 1;9(11):1505-1513. doi: 10.1001/jamaoncol.2023.3309.

    PubMed 37676681

  • Ohri N, Jolly S, Cooper BT, Kabarriti R, Bodner WR, Klein J, Guha C, Viswanathan S, Shum E, Sabari JK, Cheng H, Gucalp RA, Castellucci E, Qin A, Gadgeel SM, Halmos B. Selective Personalized RadioImmunotherapy for Locally Advanced Non-Small-Cell Lung Cancer Trial (SPRINT). J Clin Oncol. 2024 Feb 10;42(5):562-570. doi: 10.1200/JCO.23.00627. Epub 2023 Nov 21.

    PubMed 37988638

  • Li C, Tan L, Liu X, Wang X, Zhou Z, Chen D, Feng Q, Liang J, Lv J, Wang X, Bi N, Deng L, Wang W, Zhang T, Ni W, Chang X, Han W, Gao L, Wang S, Xiao Z. Concurrent chemoradiotherapy versus radiotherapy alone for patients with locally advanced esophageal squamous cell carcinoma in the era of intensity modulated radiotherapy: a propensity score-matched analysis. Thorac Cancer. 2021 Jun;12(12):1831-1840. doi: 10.1111/1759-7714.13971. Epub 2021 May 5.

    PubMed 33949784

  • Liu Y, Zheng Z, Li M, Zhang Y, Zhao F, Gong H, Lin H, Huang W, Chen X, Xu Z, Li X, Liu W, Cui Y, Zheng A, Li B. Comparison of concurrent chemoradiotherapy with radiotherapy alone for locally advanced esophageal squamous cell cancer in elderly patients: A randomized, multicenter, phase II clinical trial. Int J Cancer. 2022 Aug 15;151(4):607-615. doi: 10.1002/ijc.34030. Epub 2022 Apr 27.

    PubMed 35419831

  • Ji Y, Du X, Zhu W, Yang Y, Ma J, Zhang L, Li J, Tao H, Xia J, Yang H, Huang J, Bao Y, Du D, Liu D, Wang X, Li C, Yang X, Zeng M, Liu Z, Zheng W, Pu J, Chen J, Hu W, Li P, Wang J, Xu Y, Zheng X, Chen J, Wang W, Tao G, Cai J, Zhao J, Zhu J, Jiang M, Yan Y, Xu G, Bu S, Song B, Xie K, Huang S, Zheng Y, Sheng L, Lai X, Chen Y, Cheng L, Hu X, Ji W, Fang M, Kong Y, Yu X, Li H, Li R, Shi L, Shen W, Zhu C, Lv J, Huang R, He H, Chen M. Efficacy of Concurrent Chemoradiotherapy With S-1 vs Radiotherapy Alone for Older Patients With Esophageal Cancer: A Multicenter Randomized Phase 3 Clinical Trial. JAMA Oncol. 2021 Oct 1;7(10):1459-1466. doi: 10.1001/jamaoncol.2021.2705.

    PubMed 34351356

  • Chen Y, Ye J, Zhu Z, Zhao W, Zhou J, Wu C, Tang H, Fan M, Li L, Lin Q, Xia Y, Li Y, Li J, Jia H, Lu S, Zhang Z, Zhao K. Comparing Paclitaxel Plus Fluorouracil Versus Cisplatin Plus Fluorouracil in Chemoradiotherapy for Locally Advanced Esophageal Squamous Cell Cancer: A Randomized, Multicenter, Phase III Clinical Trial. J Clin Oncol. 2019 Jul 10;37(20):1695-1703. doi: 10.1200/JCO.18.02122. Epub 2019 Mar 28.

    PubMed 30920880

  • You J, Zhu S, Li J, Li J, Shen J, Zhao Y, Li X, Jia L, Li Q, Yang J, Wu Y, Shen W, Wu H, Wu X, Wang X, Ren Y, He J, Lin P, Zhu G, Shi A. High-Dose Versus Standard-Dose Intensity-Modulated Radiotherapy With Concurrent Paclitaxel Plus Carboplatin for Patients With Thoracic Esophageal Squamous Cell Carcinoma: A Randomized, Multicenter, Open-Label, Phase 3 Superiority Trial. Int J Radiat Oncol Biol Phys. 2023 Apr 1;115(5):1129-1137. doi: 10.1016/j.ijrobp.2022.11.006. Epub 2022 Nov 17.

    PubMed 36402359

  • Yuan Y, Luo S, Wang X, Zheng Z, Qi Q, Wang Y, Chen M, Yang H, Gu P, Du Q, Wu X, Pan W, Xu Y, Wang J. Efficacy and safety of concurrent programmed cell death protein 1 inhibitor and definitive radiotherapy with immunonutrition support in esophageal squamous cell cancer: a phase II multicenter clinical trial. Radiat Oncol. 2025 Apr 18;20(1):58. doi: 10.1186/s13014-025-02604-z.

    PubMed 40251674

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Radiotherapy, Programmed Cell Death Protein 1 Inhibitor and Immunonutrition support in people with Locally Advanced Esophageal Squamous Cell Carcinoma and Sintilimab, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 10 sites 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 19 inclusion and 30 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 7 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 10 sites 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 Jianyang Wang, MD (+86-13810095191, pkucell@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

1-year Progression-free survival rate (PFS) (time frame: From start of treatment until 1 years of follow-up.). 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 NCT06342167, which also lists 10 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 7 Oct 2026.

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