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Esophageal Squamous Cell CarcinomaPhase 2SCR-ESCC-01NCT05978193

Radiotherapy Combined With Immunochemotherapy in Metastatic Esophageal Squamous Cell Carcinoma

A Phase 2 study testing LDRT+CFRT, Immunotherapy and Chemotherapy in people with Esophageal Squamous Cell Carcinoma and Esophageal Cancer, run by Shanghai Chest Hospital at 2 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

SCR-ESCC-01 is a multicenter, randomized, phase II study aiming to investigate the benefit of early involvement of low-dose radiotherapy(LDRT) and conventionally fractionated radiotherapy(CFRT) in the first-line anti-PD-1 based treatment of metastatic ESCC. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
LDRT+CFRT, Immunotherapy and Chemotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
2 sitesChina
Study dates
1 Jan 2023to 1 Jan 2028
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥18;
  • Metastatic esophageal squamous cell carcinoma (stage IVB, M1) confirmed by pathology;
  • ECOG performance status: 0-1 point;
  • No prior anti-tumor treatment;
  • Adequate hematologic, renal, hepatic, and cardiac functions that meet the requirements for chemotherapy and immunotherapy assessed by investigators.

Who cannot join

  • Non-squamous cell esophageal carcinoma or ESCC mixed with other pathological types of esophageal cancer;
  • Patients who are potentially curable with surgery as assessed by investigators;
  • Pleural metastasis or malignant pleural effusion, pericardial effusion;
  • Any prior anti-tumor therapy for esophageal cancer, i.e., surgery, radiotherapy, chemotherapy, or immunotherapy;
  • High risk of gastrointestinal bleeding, esophageal fistula, or perforation;
  • Patients with Patient-Generated Subjective Globe Assessment (PG-SGA) score≥9;
Show all 12Show fewer
  • Unstable cardiac diseases or symptoms;
  • History of interstitial pulmonary disease, non-infectious pneumonitis; pulmonary fibrosis, or other uncontrolled acute pulmonary disease;
  • Active autoimmune disease or history of autoimmune disease;
  • Conditions of immunodeficiency or active infection requiring systemic therapy;
  • Pregnant or breastfeeding;
  • Patients with synchronous second primary cancer and a history of malignancy within the past 5 years (excluding completely cured cervical carcinoma in situ or basal cell or squamous cell skin carcinoma).

Trial locations and contacts

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

Wen Yu, M.D contact

021-22200000-3203

yuzhiwen0827@163.com

China2 sites, 2 recruiting

  • Shanghai Ruijin Hospital

    Shanghai, 200020

    Sheng-guang Zhao, 021-34186000

    Recruiting

  • Shanghai Chest Hospital

    Shanghai, 200030

    Wen Yu, 021-22200000-3203, yuzhiwen0827@163.com

    Recruiting

Other trials in China

About this study

Official title: First-line Anti-PD-1 Therapy Plus Chemotherapy With or Without Radiotherapy in Metastatic Esophageal Squamous Cell Carcinoma: A Phase II Multi-center Trial (SCR-ESCC-01)

SCR-ESCC-01 is a multicenter, randomized, phase II study aiming to investigate the benefit of early involvement of low-dose radiotherapy(LDRT) and conventionally fractionated radiotherapy(CFRT) in the first-line anti-PD-1 based treatment of metastatic ESCC. It begins with a safety run-in phase, followed by a randomized controlled comparison against standard immunochemotherapy.

Read the detailed description

In metastatic esophageal squamous cell carcinoma (ESCC), radiotherapy is often administered for palliative purposes to alleviate dysphagia. Recent studies suggest that combining radiotherapy with immunotherapy may have a synergistic effect on treatment outcomes. This study aims to investigate the efficacy and safety of adding Low-Dose Radiotherapy (LDRT) combined with Conventionally Fractionated Radiotherapy (CFRT) to first-line immunochemotherapy.

Study Design:The protocol follows a sequential two-phase design:

  1. Phase IIa (Safety Run-in / Pilot Phase):An initial cohort of approximately 20-25 patients will receive the experimental regimen (LDRT + CFRT + Immunochemotherapy) in a single-arm setting. The primary objective of this phase is to evaluate safety and feasibility. Safety Stopping Rule: A strict stopping rule is defined for the transition to the randomized phase. If 2 or more patients in the run-in cohort experience treatment-related death (Grade 5 Treatment-Related Adverse Events), the study will be terminated and will not proceed to Phase IIb.
  2. Phase IIb (Randomized Controlled Phase):Upon confirmation that the safety criteria are met (i.e., < 2 treatment-related deaths and acceptable toxicity profile), subsequent patients will be randomly assigned (1:1) to:

Arm A (Experimental): PD-1 inhibitor plus chemotherapy (paclitaxel and platinum regimen) combined with LDRT and CFRT.

Arm B (Control): PD-1 inhibitor plus chemotherapy alone. Primary Endpoint:The primary endpoint for the randomized phase is median progression-free survival (PFS).

Being tested
LDRT+CFRT, Immunotherapy, Chemotherapy
Keywords
Immunotherapy, low-dose radiotherapy, Esophageal squamous cell carcinoma, Immunoradiotherapy
Medical subject headings
Esophageal Squamous Cell Carcinoma, Esophageal Neoplasms

What participants receive

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

  • LDRT+CFRTRadiation

    LDRT: Primary tumor and all visible metastatic lesions, DT: 2Gy/2fx, d1-2, Q3W × 4 cycles

    ; CFRT: Primary tumor, DT:40-50Gy/20-25fx, starting from the 5th immunotherapy cycle

  • ImmunotherapyDrug

    PD-1 inhibitor 200mg, Q3W, until disease progression or unacceptable toxicity or treatment reaches 2 years

  • ChemotherapyDrug

    Paclitaxel+ Cisplatin, Q3W × 4cycles or Paclitaxel+ Carboplatin, Q3W × 4 cycles

Study groups in NCT05978193
Study groupRoleWhat they receive
Arm AExperimentalPD-1 inhibitor + Paclitaxel + Cisplatin/Carboplatin+ Low-dose radiotherapy (LDRT) + Conventionally fractionated radiotherapy (CFRT)
Receives: Radiation: LDRT+CFRT; Drug: Immunotherapy; Drug: Chemotherapy
Arm BActive comparatorPD-1 inhibitor + Paclitaxel + Cisplatin/Carboplatin
Receives: Drug: Immunotherapy; Drug: Chemotherapy
Safety Run-in CohortExperimentalSingle Arm, LDRT + CFRT + Immunochemotherapy
Receives: Radiation: LDRT+CFRT; Drug: Immunotherapy; Drug: Chemotherapy

What is being measured

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

  1. PFS

    Progression-free survival

    Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months

  2. Safety and Feasibility of the Combined Regimen (Safety Run-in Phase)

    Incidence of Treatment-Related Adverse Events (TRAEs) in the initial cohort.

    Measured: From start of treatment up to 30 days after the last dose.

Secondary outcomes (2)

  1. OS

    Median overall survival

    Measured: From date of randomization until the date of death from any cause, assessed up to 36 months

  2. Incidence of Grade III and higher treatment-related adverse events

    Measured: 1 year

Timeline

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

  1. First posted7 Aug 2023
  2. Study start1 Jan 2023
  3. Primary completionJan 2027 (estimated)
  4. Study completion1 Jan 2028 (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
Randomised
Intervention model
Sequential
Model description
Includes a single-arm safety run-in followed by randomization.
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05978193
Sponsor's protocol ID
SCR-ESCC-01
Acronym
SCR-ESCC-01
Status last verified
Jan 2026
First submitted
28 Jul 2023
Last updated
22 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sun JM, Shen L, Shah MA, Enzinger P, Adenis A, Doi T, Kojima T, Metges JP, Li Z, Kim SB, Cho BC, Mansoor W, Li SH, Sunpaweravong P, Maqueda MA, Goekkurt E, Hara H, Antunes L, Fountzilas C, Tsuji A, Oliden VC, Liu Q, Shah S, Bhagia P, Kato K; KEYNOTE-590 Investigators. Pembrolizumab plus chemotherapy versus chemotherapy alone for first-line treatment of advanced oesophageal cancer (KEYNOTE-590): a randomised, placebo-controlled, phase 3 study. Lancet. 2021 Aug 28;398(10302):759-771. doi: 10.1016/S0140-6736(21)01234-4.

    PubMed 34454674

  • Luo H, Lu J, Bai Y, Mao T, Wang J, Fan Q, Zhang Y, Zhao K, Chen Z, Gao S, Li J, Fu Z, Gu K, Liu Z, Wu L, Zhang X, Feng J, Niu Z, Ba Y, Zhang H, Liu Y, Zhang L, Min X, Huang J, Cheng Y, Wang D, Shen Y, Yang Q, Zou J, Xu RH; ESCORT-1st Investigators. Effect of Camrelizumab vs Placebo Added to Chemotherapy on Survival and Progression-Free Survival in Patients With Advanced or Metastatic Esophageal Squamous Cell Carcinoma: The ESCORT-1st Randomized Clinical Trial. JAMA. 2021 Sep 14;326(10):916-925. doi: 10.1001/jama.2021.12836.

    PubMed 34519801

  • Lu Z, Wang J, Shu Y, Liu L, Kong L, Yang L, Wang B, Sun G, Ji Y, Cao G, Liu H, Cui T, Li N, Qiu W, Li G, Hou X, Luo H, Xue L, Zhang Y, Yue W, Liu Z, Wang X, Gao S, Pan Y, Galais MP, Zaanan A, Ma Z, Li H, Wang Y, Shen L; ORIENT-15 study group. Sintilimab versus placebo in combination with chemotherapy as first line treatment for locally advanced or metastatic oesophageal squamous cell carcinoma (ORIENT-15): multicentre, randomised, double blind, phase 3 trial. BMJ. 2022 Apr 19;377:e068714. doi: 10.1136/bmj-2021-068714.

    PubMed 35440464

  • Wang ZX, Cui C, Yao J, Zhang Y, Li M, Feng J, Yang S, Fan Y, Shi J, Zhang X, Shen L, Shu Y, Wang C, Dai T, Mao T, Chen L, Guo Z, Liu B, Pan H, Cang S, Jiang Y, Wang J, Ye M, Chen Z, Jiang D, Lin Q, Ren W, Wang J, Wu L, Xu Y, Miao Z, Sun M, Xie C, Liu Y, Wang Q, Zhao L, Li Q, Huang C, Jiang K, Yang K, Li D, Liu Y, Zhu Z, Chen R, Jia L, Li W, Liao W, Liu HX, Ma D, Ma J, Qin Y, Shi Z, Wei Q, Xiao K, Zhang Y, Zhang Y, Chen X, Dai G, He J, Li J, Li G, Liu Y, Liu Z, Yuan X, Zhang J, Fu Z, He Y, Ju F, Liu Z, Tang P, Wang T, Wang W, Zhang J, Luo X, Tang X, May R, Feng H, Yao S, Keegan P, Xu RH, Wang F. Toripalimab plus chemotherapy in treatment-naive, advanced esophageal squamous cell carcinoma (JUPITER-06): A multi-center phase 3 trial. Cancer Cell. 2022 Mar 14;40(3):277-288.e3. doi: 10.1016/j.ccell.2022.02.007. Epub 2022 Mar 3.

    PubMed 35245446

  • Herrera FG, Bourhis J, Coukos G. Radiotherapy combination opportunities leveraging immunity for the next oncology practice. CA Cancer J Clin. 2017 Jan;67(1):65-85. doi: 10.3322/caac.21358. Epub 2016 Aug 29.

    PubMed 27570942

  • Shaverdian N, Lisberg AE, Bornazyan K, Veruttipong D, Goldman JW, Formenti SC, Garon EB, Lee P. Previous radiotherapy and the clinical activity and toxicity of pembrolizumab in the treatment of non-small-cell lung cancer: a secondary analysis of the KEYNOTE-001 phase 1 trial. Lancet Oncol. 2017 Jul;18(7):895-903. doi: 10.1016/S1470-2045(17)30380-7. Epub 2017 May 24.

    PubMed 28551359

  • Theelen WSME, Peulen HMU, Lalezari F, van der Noort V, de Vries JF, Aerts JGJV, Dumoulin DW, Bahce I, Niemeijer AN, de Langen AJ, Monkhorst K, Baas P. Effect of Pembrolizumab After Stereotactic Body Radiotherapy vs Pembrolizumab Alone on Tumor Response in Patients With Advanced Non-Small Cell Lung Cancer: Results of the PEMBRO-RT Phase 2 Randomized Clinical Trial. JAMA Oncol. 2019 Sep 1;5(9):1276-1282. doi: 10.1001/jamaoncol.2019.1478.

    PubMed 31294749

  • Herrera FG, Ronet C, Ochoa de Olza M, Barras D, Crespo I, Andreatta M, Corria-Osorio J, Spill A, Benedetti F, Genolet R, Orcurto A, Imbimbo M, Ghisoni E, Navarro Rodrigo B, Berthold DR, Sarivalasis A, Zaman K, Duran R, Dromain C, Prior J, Schaefer N, Bourhis J, Dimopoulou G, Tsourti Z, Messemaker M, Smith T, Warren SE, Foukas P, Rusakiewicz S, Pittet MJ, Zimmermann S, Sempoux C, Dafni U, Harari A, Kandalaft LE, Carmona SJ, Dangaj Laniti D, Irving M, Coukos G. Low-Dose Radiotherapy Reverses Tumor Immune Desertification and Resistance to Immunotherapy. Cancer Discov. 2022 Jan;12(1):108-133. doi: 10.1158/2159-8290.CD-21-0003. Epub 2021 Sep 3.

    PubMed 34479871

  • Yin L, Xue J, Li R, Zhou L, Deng L, Chen L, Zhang Y, Li Y, Zhang X, Xiu W, Tong R, Gong Y, Huang M, Xu Y, Zhu J, Yu M, Li M, Lan J, Wang J, Mo X, Wei Y, Niedermann G, Lu Y. Effect of Low-Dose Radiation Therapy on Abscopal Responses to Hypofractionated Radiation Therapy and Anti-PD1 in Mice and Patients With Non-Small Cell Lung Cancer. Int J Radiat Oncol Biol Phys. 2020 Sep 1;108(1):212-224. doi: 10.1016/j.ijrobp.2020.05.002. Epub 2020 May 15.

    PubMed 32417411

  • Li Y, Lin L, Liu J, Cai XW, Zhang Q, Song XY, Zhao SG, Ma XM, Fu XL, Yu W. Phase II multicenter trial: first-line immunochemotherapy with or without radiotherapy in metastatic esophageal squamous cell cancer (SCR-ESCC-01). Future Oncol. 2023 Nov;19(34):2291-2296. doi: 10.2217/fon-2023-0674. Epub 2023 Nov 8.

    PubMed 37937444

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LDRT+CFRT, Immunotherapy and Chemotherapy in people with Esophageal Squamous Cell Carcinoma and Esophageal Cancer, run by Shanghai Chest Hospital at 2 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 5 inclusion and 12 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 22 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 2 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 Wen Yu, M.D (021-22200000-3203, yuzhiwen0827@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PFS (time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months). The study lists 2 primary outcomes in all. 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 NCT05978193, 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 22 Jan 2026.

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