Esophageal CancerPhase 3EC-CRT-008NCT07177794
Consolidation of Toripalimab and Capecitabine After Chemoradiotherapy in ESCC
A Phase 3 study testing toripalimab and capecitabine in people with Esophageal Cancer and Chemoradiotherapy, run by Sun Yat-sen University at 1 site in China.
Trial summary
Definitive chemoradiotherapy (CRT) is the standard treatment for locally advanced unresectable esophageal cancer, but its efficacy remains unsatisfactory. More importantly, there is a lack of effective consolidation treatment after CRT, resulting in a high recurrence rate. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Cancer, Chemoradiotherapy
- What is being tested?
- toripalimab and capecitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- 1 siteChina
- Study dates
- 10 Sep 2025to 31 May 2030
- Phase
- Phase 3
- 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
- Histologically confirmed squamous cell carcinoma of the esophagus;
- Locally advanced esophageal cancer classified as stage I-IVA (inoperable or patient declined surgery) or stage IVB thoracic esophageal cancer with supraclavicular lymph node metastasis only (AJCC 8th edition) prior to treatment;
- Completion of definitive concurrent chemoradiotherapy without disease progression; radiotherapy dose of 50-50.4 Gy using conventional fractionation and IMRT technique; concurrent platinum- or taxane-based doublet chemotherapy during radiotherapy; ≤4 cycles of induction chemotherapy allowed prior to radiotherapy; PD-1/PD-L1 antibody therapy permitted during induction chemotherapy and radiotherapy; no adjuvant therapy received;
- Enrollment window: within 1-42 days after completion of chemoradiotherapy;
- Age 18-75 years;
- Estimated life expectancy >6 months;
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- Eastern Cooperative Oncology Group performance status ≤ 2;
- The function of important organs meets the following requirements: a. white blood cell count (WBC) ≥3.5×109/L, absolute neutrophil count (ANC) ≥1.5×109/L; b. platelets ≥75×109/L; c. hemoglobin ≥9g/dL; d. serum albumin ≥2.8g/dL; e. total bilirubin ≤1.5×ULN, ALT, AST and/or AKP ≤2.5×ULN; f. serum creatinine ≤1.5×ULN or creatinine clearance rate >60 mL/min;
- Ability to understand the trial details and has provided written informed consent.
Who cannot join
- Patients who have received antitumor therapy (including adjuvant chemotherapy, surgery, immunotherapy, targeted therapy, etc.) after completion of chemoradiotherapy;
- Stage IVb patients with metastasis to solid organs (e.g., liver, bone, lung, brain, adrenal gland, peritoneum, etc.) at initial diagnosis;
- Known or suspected allergy to the investigational drug(s) or any agent related to the trial regimen;
- Presence of esophageal fistula and/or esophageal hemorrhage prior to enrollment;
- Disease progression after chemoradiotherapy;
- ≥Grade 2 radiation pneumonitis prior to enrollment;
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- History of ≥ Grade 3 immune-related adverse events prior to enrollment;
- Prior treatment with targeted drugs;
- History of other malignant tumors besides esophageal cancer, except for non-melanoma skin cancer, carcinoma in situ of the cervix, papillary thyroid carcinoma, or cured early-stage prostate cancer;
- Patients with severe cardiac, pulmonary, hepatic, or renal dysfunction, hematopoietic system diseases, cachexia, or other conditions that make them unfit for chemotherapy;
- Female patients who are pregnant or breastfeeding;
- Inability to provide informed consent due to psychological, familial, social, or other factors;
- Presence of CTC grade ≥2 peripheral neuropathy;
- Patients with a history of diabetes for more than 10 years and poorly controlled blood glucose levels;
- History of autoimmune disease or autoimmune disorders (e.g., colitis, systemic lupus erythematosus, rheumatoid arthritis, uveitis, hypophysitis, hyperthyroidism; not limited to these diseases or syndromes), immunodeficiency history, including HIV positivity, or other acquired/congenital immunodeficiency disorders, or history of organ transplantation or allogeneic bone marrow transplantation;
- History of interstitial lung disease or non-infectious pneumonia;
- Active hepatitis B (HBV DNA ≥2000 IU/mL or 10⁴ copies/mL) or hepatitis C (HCV antibody positive with HCV-RNA above the lower limit of detection);
- Any unstable condition that may jeopardize patient safety or compliance.
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, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Mian XI, MD, 862087343385, ximian@sysucc.org.cn
Mian XI, MD
About this study
Official title: Toripalimab Combined With Capecitabine as Maintenance Therapy After Definitive Chemoradiotherapy for Esophageal Squamous Cell Carcinoma: a Multicenter, Randomized Controlled, Phase III Trial (EC-CRT-008)
Definitive chemoradiotherapy (CRT) is the standard treatment for locally advanced unresectable esophageal cancer, but its efficacy remains unsatisfactory. More importantly, there is a lack of effective consolidation treatment after CRT, resulting in a high recurrence rate. Our previous prospective phase II trial (EC-CRT-001) demonstrated that the addition of toripalimab to definitive CRT improved the complete response rate in patients with locally advanced esophageal squamous cell carcinoma (ESCC), showing potential for enhanced long-term survival with a manageable safety profile. Nevertheless, the risk of recurrence requires further reduction. Metronomic capecitabine chemotherapy can modulate the tumor immune microenvironment and may synergize with PD-1 antibodies to enhance antitumor efficacy, potentially further prolonging survival in ESCC. Based on current research advances and our preliminary findings, this randomized, controlled, multicenter, phase III clinical trial aims to evaluate the efficacy and safety of toripalimab combined with capecitabine as maintenance therapy for patients with locally advanced ESCC who have not progressed after definitive CRT.
- Conditions
- Esophageal Cancer, Chemoradiotherapy
- Being tested
- toripalimab, capecitabine
- Keywords
- Esophageal squamous cell carcinoma, definitive chemoradiotherapy, maintenance therapy, Toripalimab
- Medical subject headings
- Esophageal Neoplasms, Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
toripalimabDrug
Also called JS001
Patients will receive toripalimab with a maximum treatment duration of one year (240 mg, IV drip, Q3W, for 16 cycles).
capecitabineDrug
Also called Xeloda
Patients will receive metronomic capecitabine, with a maximum treatment duration of one year (500 mg, twice daily, orally).
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Patients will receive toripalimab combined with metronomic capecitabine, with a maximum treatment duration of one year (toripalimab 240 mg, IV drip, Q3W, for 16 cycles; capecitabine 500 mg, twice daily, orally). Receives: Drug: toripalimab; Drug: capecitabine |
| Arm B | No intervention | Patients will undergo conventional observation and follow-up. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Three-year follow-up from the date of enrollment to the date of disease progression or last follow-up
Measured: From date of enrollment until the date of death from any cause or the date of first documented disease progression whichever came first, assessed up to 36 months
Secondary outcomes (3)
Overall survival
Three-year follow-up from the enrollment to the date of death from any cause or date of lost follow-up
Measured: From date of enrollment until the date of death from any cause or the date of last follow-up, whichever came first, assessed up to 36 months
Clinical complete response
Tumor response was evaluated 14-16 weeks after the completion of radiotherapy based on CT or PET-CT scans, and endoscopy with biopsies.
Measured: 14-16 weeks after the completion of radiotherapy
Treatment-related adverse events
Incidence of treatment-related adverse events as assessed by CTCAE v4.0.
Measured: From date of enrollment to the date of last follow-up, assessed up to 36 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2025
- Study start10 Sep 2025
- Primary completion31 May 2028 (estimated)
- Study completion31 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 242 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital, Sun Yat-Sen University, Fifth Affiliated Hospital, Sun Yat-Sen University, Zhongshan People's Hospital, Guangdong, China
- Responsible party
- Principal investigator, Mian XI, Sun Yat-sen University
- Investigators
- Mian Xi, MD, Principal investigator, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07177794
- Sponsor's protocol ID
- B2025-404-01
- Acronym
- EC-CRT-008
- Status last verified
- Apr 2026
- First submitted
- 10 Sep 2025
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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 36990609Bando H, Kumagai S, Kotani D, Mishima S, Irie T, Itahashi K, Tanaka Y, Habu T, Fukaya S, Kondo M, Tsushima T, Hara H, Kadowaki S, Kato K, Chin K, Yamaguchi K, Kageyama SI, Hojo H, Nakamura M, Tachibana H, Wakabayashi M, Fukui M, Fuse N, Koyama S, Mano H, Nishikawa H, Shitara K, Yoshino T, Kojima T. Atezolizumab following definitive chemoradiotherapy in patients with unresectable locally advanced esophageal squamous cell carcinoma - a multicenter phase 2 trial (EPOC1802). Nat Cancer. 2025 Mar;6(3):445-459. doi: 10.1038/s43018-025-00918-1. Epub 2025 Feb 19.
PubMed 39972105Jia R, Shan T, Zheng A, Zhang Y, Lu P, Zhang G, Wang F, Xu Z, Zheng G, Tang D, Zhang W, Li W, Li R, Guo Y, Liu L, Luo X, Zheng Y, Chang Z, Wang Q, Wang X, Yuan X, Kong G, Li S, Yang R, Zhou D, Ren J, Yin W, Li J, Zhang J, Wang Z, Sheng M, Xu B, Li L, Liu X, Lu Z, Wan L, Zhou F, Gao S. Capecitabine or Capecitabine Plus Oxaliplatin Versus Fluorouracil Plus Cisplatin in Definitive Concurrent Chemoradiotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma (CRTCOESC): A Multicenter, Randomized, Open-Label, Phase 3 Trial. J Clin Oncol. 2024 Jul 10;42(20):2436-2445. doi: 10.1200/JCO.23.02009. Epub 2024 May 6.
PubMed 38710003
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Toripalimab Combined With Capecitabine as Maintenance Therapy After Definitive Chemoradiotherapy for Esophageal Squamous Cell Carcinoma: a Multicenter, Randomized Controlled, Phase III Trial (EC-CRT-008)
- ClinicalTrials.gov ID
- NCT07177794
- Acronym / sponsor ID
- EC-CRT-008 / B2025-404-01
- Conditions
- Esophageal Cancer, Chemoradiotherapy
- Keywords
- Esophageal squamous cell carcinoma, definitive chemoradiotherapy, maintenance therapy, Toripalimab
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 242 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- First Affiliated Hospital, Sun Yat-Sen University, Fifth Affiliated Hospital, Sun Yat-Sen University, Zhongshan People's Hospital, Guangdong, China
- Study start
- 10 Sep 2025 (actual)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 May 2030 (estimated)
- First posted
- 17 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Definitive chemoradiotherapy (CRT) is the standard treatment for locally advanced unresectable esophageal cancer, but its efficacy remains unsatisfactory. More importantly, there is a lack of effective consolidation treatment after CRT, resulting in a high recurrence rate. Our previous prospective phase II trial (EC-CRT-001) demonstrated that the addition of toripalimab to definitive CRT improved the complete response rate in patients with locally advanced esophageal squamous cell carcinoma (ESCC), showing potential for enhanced long-term survival with a manageable safety profile. Nevertheless, the risk of recurrence requires further reduction. Metronomic capecitabine chemotherapy can modulate the tumor immune microenvironment and may synergize with PD-1 antibodies to enhance antitumor efficacy, potentially further prolonging survival in ESCC. Based on current research advances and our preliminary findings, this randomized, controlled, multicenter, phase III clinical trial aims to evaluate the efficacy and safety of toripalimab combined with capecitabine as maintenance therapy for patients with locally advanced ESCC who have not progressed after definitive CRT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: toripalimab, Drug: capecitabinePatients will receive toripalimab combined with metronomic capecitabine, with a maximum treatment duration of one year (toripalimab 240 mg, IV drip, Q3W, for 16 cycles; capecitabine 500 mg, twice daily, orally). |
| Arm B | No intervention | –Patients will undergo conventional observation and follow-up. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically confirmed squamous cell carcinoma of the esophagus;
- Locally advanced esophageal cancer classified as stage I-IVA (inoperable or patient declined surgery) or stage IVB thoracic esophageal cancer with supraclavicular lymph node metastasis only (AJCC 8th edition) prior to treatment;
- Completion of definitive concurrent chemoradiotherapy without disease progression; radiotherapy dose of 50-50.4 Gy using conventional fractionation and IMRT technique; concurrent platinum- or taxane-based doublet chemotherapy during radiotherapy; ≤4 cycles of induction chemotherapy allowed prior to radiotherapy; PD-1/PD-L1 antibody therapy permitted during induction chemotherapy and radiotherapy; no adjuvant therapy received;
- Enrollment window: within 1-42 days after completion of chemoradiotherapy;
- Age 18-75 years;
Key exclusion criteria (18 listed)
- Patients who have received antitumor therapy (including adjuvant chemotherapy, surgery, immunotherapy, targeted therapy, etc.) after completion of chemoradiotherapy;
- Stage IVb patients with metastasis to solid organs (e.g., liver, bone, lung, brain, adrenal gland, peritoneum, etc.) at initial diagnosis;
- Known or suspected allergy to the investigational drug(s) or any agent related to the trial regimen;
- Presence of esophageal fistula and/or esophageal hemorrhage prior to enrollment;
- Disease progression after chemoradiotherapy;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| toripalimabAlso: JS001Patients will receive toripalimab with a maximum treatment duration of one year (240 mg, IV drip, Q3W, for 16 cycles). | Drug | Arm A |
| capecitabineAlso: XelodaPatients will receive metronomic capecitabine, with a maximum treatment duration of one year (500 mg, twice daily, orally). | Drug | Arm A |
Primary outcome
Progression-free survival
Time frame: From date of enrollment until the date of death from any cause or the date of first documented disease progression whichever came first, assessed up to 36 months
Three-year follow-up from the date of enrollment to the date of disease progression or last follow-up
3 secondary outcomes
Overall survival
Time frame: From date of enrollment until the date of death from any cause or the date of last follow-up, whichever came first, assessed up to 36 months
Clinical complete response
Time frame: 14-16 weeks after the completion of radiotherapy
Treatment-related adverse events
Time frame: From date of enrollment to the date of last follow-up, assessed up to 36 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Results publication: PubMed 36990609Zhu 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.
- Results publication: PubMed 39972105Bando H, Kumagai S, Kotani D, Mishima S, Irie T, Itahashi K, Tanaka Y, Habu T, Fukaya S, Kondo M, Tsushima T, Hara H, Kadowaki S, Kato K, Chin K, Yamaguchi K, Kageyama SI, Hojo H, Nakamura M, Tachibana H, Wakabayashi M, Fukui M, Fuse N, Koyama S, Mano H, Nishikawa H, Shitara K, Yoshino T, Kojima T. Atezolizumab following definitive chemoradiotherapy in patients with unresectable locally advanced esophageal squamous cell carcinoma - a multicenter phase 2 trial (EPOC1802). Nat Cancer. 2025 Mar;6(3):445-459. doi: 10.1038/s43018-025-00918-1. Epub 2025 Feb 19.
- Results publication: PubMed 38710003Jia R, Shan T, Zheng A, Zhang Y, Lu P, Zhang G, Wang F, Xu Z, Zheng G, Tang D, Zhang W, Li W, Li R, Guo Y, Liu L, Luo X, Zheng Y, Chang Z, Wang Q, Wang X, Yuan X, Kong G, Li S, Yang R, Zhou D, Ren J, Yin W, Li J, Zhang J, Wang Z, Sheng M, Xu B, Li L, Liu X, Lu Z, Wan L, Zhou F, Gao S. Capecitabine or Capecitabine Plus Oxaliplatin Versus Fluorouracil Plus Cisplatin in Definitive Concurrent Chemoradiotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma (CRTCOESC): A Multicenter, Randomized, Open-Label, Phase 3 Trial. J Clin Oncol. 2024 Jul 10;42(20):2436-2445. doi: 10.1200/JCO.23.02009. Epub 2024 May 6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mian Xi, MD principal investigator
Sun Yat-Sen University Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing toripalimab and capecitabine in people with Esophageal Cancer and Chemoradiotherapy, run by Sun Yat-sen 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 18 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 21 Apr 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Mian Xi, MD (862087343385, ximian@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: From date of enrollment until the date of death from any cause or the date of first documented disease progression whichever came first, assessed up to 36 months). 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 NCT07177794, which also lists 3 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 21 Apr 2026.