ESCCPhase 2VISTA-ESCCNCT07892833
Becotatug Vedotin in Combination With Immunotherapy and Multimodality Radiotherapy for Esophageal Squamous Cell Carcinoma in the Second-line or Later Setting
A Phase 2 study testing Becotatug vedotin (MRG003) in people with ESCC, run by The First Affiliated Hospital of Bengbu Medical University at 1 site in China.
Trial summary
This is a prospective, single-arm, exploratory, single-center clinical study designed to evaluate the efficacy and safety of becotatug vedotin (MRG003) in combination with an investigator's choice of immune checkpoint inhibitor (ICI) plus multimodal radiotherapy in patients with advanced esophageal squamous cell… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- ESCC
- What is being tested?
- Becotatug vedotin (MRG003)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2026to 30 Apr 2029
- 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
- Patients voluntarily participated in the trial, fully informed consent, signed written informed consent, and had good compliance;
- Age of 18-80 years old (including the cut-off value), male or female;
- Recurrent/metastatic or unresectable advanced esophageal squamous cell carcinoma confirmed by pathology or histology;
- Failure of at least one previous standard therapy (including chemotherapy, PD-1 or PD-L1 inhibitors, etc.);
- At least one baseline extracranial measurable lesion, according to RECIST 1.1 criteria (≥10 mm in the greatest dimension on CT scan or ≥15 mm in the short dimension if the lesion is a lymph node), that had not received radiation therapy or had received previous local radiation therapy but was considered by the investigator to be reirradiated;
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-1;
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- Expected survival time ≥12 weeks;
- The expression of epidermal growth factor receptor (EGFR) was confirmed by immunohistochemistry (IHC 1+,2+,3+);
- Previous antineoplastic treatment-related aes of NCI Common Terminology for Adverse Events version 5.0 (NCI CTCAE v5.0) ≤ grade 1 (except alopecia, non-clinically significant or asymptomatic laboratory abnormalities);
- The organ and bone marrow are sufficiently functional to meet the following requirements (within 14 days before starting study treatment) : 1) Blood routine examination: no blood transfusion, no use of granulocyte colony-stimulating factor [G-CSF], and no drug correction within 14 days before screening: hemoglobin [HB] ≥90g/L; Absolute neutrophil count (ANC) ≥1.5×109/L; Platelet (PLT) ≥75×109/L; 2) Blood biochemical tests should meet the following criteria (no albumin transfusion within 14 days before screening) : serum total bilirubin (BIL) ≤2×ULN (Gilbert's syndrome patients ≤3×ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5.0×ULN; Serum creatinine [Cr] ≤1.5×ULN or endogenous creatinine clearance ≥50ml/min (Cockcroft-Gault formula) Male: Cr clearance =((140-age)× body weight)/(72× blood Cr) Female: Cr clearance =((140-age)× weight)/(72× blood Cr) × 0.85 (Body weight: kg; blood Cr: mg/mL). 3) Coagulation function: international normalized ratio (INR) ≤2 or prothrombin time (PT) exceeding the upper limit of normal range ≤6 seconds;
- Female subjects of childbearing potential must take a urine or serum pregnancy test within 7 days before the first dose (if the urine pregnancy test result cannot be confirmed as negative, the serum pregnancy test should be taken, and the result is negative);
- If a female subject of childbearing potential has sex with an unsterilized male partner, the subject must be using an acceptable contraceptive method from the time of screening and must agree to continue using the method for 180 days after the last dose of study drug;
- If an unsterilized male subject has sex with a fertile female partner, the subject must use an effective method of contraception from the start of screening until 180 days after the last dose of medication; Discontinuation of contraception after this time point should be discussed with the investigator.
- Participants are willing and able to comply with the scheduled visits, treatment protocols, laboratory tests, and other requirements of the study.
Who cannot join
- The presence of symptomatic or untreated known brain metastases or other central nervous system metastases that were completely resected and/or demonstrated to be stable or improved after radiotherapy were not exclusion criteria, as long as they were stable on computed tomography (CT) for at least 4 weeks before screening, had no evidence of cerebral edema, and did not require glucocorticoids or anticonvulsants;
- The subjects had a malignancy other than esophageal squamous cell carcinoma within 5 years before enrollment. Note: Skin basal cell carcinoma, superficial bladder cancer, skin squamous cell carcinoma, or cervical cancer in situ were excluded. Or patients who had received curative treatment and had not relapsed within 5 years could participate in the trial;
- Known to be allergic to a drug or a drug component;
- Previous treatment interruption due to severe and/or life-threatening immune-related toxicity;
- NCI-CTCAE v5.0 grade of adverse events caused by previous antineoplastic therapy did not recover to ≤1 before enrollment (except alopecia or antineoplastic therapy-induced tolerable events according to investigator's opinion);
- Have received or are receiving any of the following: a) being treated with an immunosuppressive drug or systemic hormone for immunosuppression (at a dose of >10 mg/ day of prednisone or equivalent) within 2 weeks before the first dose of the study drug; Use of inhaled or topical steroids and replacement adrenocortical hormones at a dose of more than 10 mg per day of prednisone or equivalent were allowed in the absence of active autoimmune disease. b) have received a live attenuated vaccine within 4 weeks before the first dose of study drug, or plan to receive a live or live attenuated vaccine during the study; c) major surgery or severe trauma within 4 weeks before the first dose of study drug;
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- Have any active autoimmune disease or history of autoimmune disease, including but not limited to: interstitial pneumonia, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (may be considered after hormone replacement therapy); Patients with psoriasis or complete remission of childhood asthma/allergies without any intervention in adulthood were considered for inclusion, but patients requiring medical intervention with bronchodilators were not included.
- A history of immunodeficiency, including HIV positivity, other acquired or congenital immunodeficiency disorders, or organ or allogeneic bone marrow transplantation;
- Presence of uncontrolled cardiac symptoms or diseases, including but not limited to: heart failure above NYHA class Ⅱ, unstable angina pectoris, myocardial infarction within 1 year, and clinically significant supraventricular or ventricular arrhythmias without clinical intervention or poorly controlled after clinical intervention;
- Severe infection (CTCAE > 2) occurred within 4 weeks before the first dose of study drug, such as severe pneumonia requiring hospitalization, bacteremia, infectious complications, etc. Patients who had active pulmonary inflammation on baseline chest imaging, had signs and symptoms of infection within 14 days before the first dose of the study drug, or required treatment with oral or intravenous antibiotics, except those who received prophylactic antibiotics;
- Patients with active pulmonary tuberculosis infection detected by medical history or CT examination, or with a history of active pulmonary tuberculosis infection within 1 year before enrollment, or with a history of active pulmonary tuberculosis infection more than 1 year before enrollment but without regular treatment;
- Presence of active hepatitis B (HBV DNA ≥ 2000 IU/mL or 104 copies/mL), hepatitis C (hepatitis C antibody positive and HCV RNA above the detection limit of the analytical method);
- Patients with clinically significant bleeding symptoms or clear bleeding tendency within 3 months before enrollment, such as daily cough/hemoptysis 2.5 mL or more lower gastrointestinal bleeding, esophageal and gastric varices with bleeding risk, bleeding gastric ulcer or angiitis;
- Arterial/venous thrombotic events occurred within 6 months before enrollment, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism;
- Pregnant or lactating women;
- According to the investigator's judgment, there are other factors that may lead to the forced termination of the study, such as other serious diseases (including mental diseases) requiring concomitant treatment, alcoholism, drug abuse, family or social factors, and factors that may affect the safety or compliance of the subjects;
- Is participating in another clinical study, unless it is an observational (noninterventional) clinical study or an interventional study follow-up.
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
The First Affiliated Hospital of Bengbu Medical University
Bengbu, Anhui, 233000
Hongwei Li, MD, +86-0552-3097010, hongweili@bbmu.edu.cn
About this study
Official title: A Prospective, Single-Arm, Exploratory Clinical Study of Vebreltinib Antibody-Drug Conjugate (EGFR-ADC) in Combination With Investigator-Selected Immune Checkpoint Inhibitors and Multimodal Radiotherapy for Second-Line and Beyond Treatment of Advanced Esophageal Squamous Cell Carcinoma
This is a prospective, single-arm, exploratory, single-center clinical study designed to evaluate the efficacy and safety of becotatug vedotin (MRG003) in combination with an investigator's choice of immune checkpoint inhibitor (ICI) plus multimodal radiotherapy in patients with advanced esophageal squamous cell carcinoma (ESCC) in the second-line or later setting.
Treatment regimen for eligible subjects:
Read more
Becotatug vedotin (MRG003): 2.0 mg/kg, administered intravenously on Day 1 of each 21-day cycle (Q3W), starting at least 30 minutes after completion of the ICI infusion.
Immune checkpoint inhibitor: Investigator's choice, including but not limited to camrelizumab, tislelizumab, and pembrolizumab; Q3W, IV, Day 1, with infusion duration per the respective prescribing information.
Multimodal radiotherapy: Initiated within the first 2 cycles of systemic therapy (no later than the end of Cycle 2), targeting the primary lesion and/or metastatic lesions. An individualized radiotherapy plan is delivered, using conventionally fractionated radiotherapy or stereotactic body radiotherapy (SBRT), at approximately 50-60 Gy in 25-30 fractions (or a biologically equivalent dose/fractionation schedule). Investigators may appropriately adjust the timing, dose, and fractionation. Whether the ICI is withheld during radiotherapy is left to the investigator's discretion based on the patient's clinical condition.
Read the detailed description
This prospective, single-arm, exploratory, single-center study evaluates the efficacy and safety of becotatug vedotin (MRG003) plus an investigator's choice of immune checkpoint inhibitor (ICI) and multimodal radiotherapy in patients with previously treated advanced esophageal squamous cell carcinoma (ESCC).
Eligibility: Histologically confirmed recurrent, metastatic, or unresectable advanced ESCC; ECOG PS 0-1; failure of ≥1 prior standard first-line regimen (which may include PD-1/PD-L1 inhibitors, alone or in combination) due to progression or unacceptable toxicity; EGFR-positive (≥1+) by immunohistochemistry; ≥1 measurable lesion per RECIST v1.1; and able to tolerate radiotherapy. Because MRG003 is an EGFR-directed antibody-drug conjugate (EGFR-MMAE), IHC-confirmed EGFR positivity is required to ensure efficacy and avoid off-target toxicity.
Study design: Screening, treatment, and follow-up periods. During treatment, patients receive MRG003 with an investigator-selected PD-1/PD-L1 inhibitor or CTLA-4-containing ICI, chosen according to disease status, guideline recommendations, and prior data. Radiotherapy is started within the first two cycles (no later than the end of Cycle 2, before Cycle 3), targeting the primary or metastatic lesions, as conventionally fractionated radiotherapy or SBRT; timing, dose, and fractionation may be adjusted by the investigator.
After signing informed consent, eligible patients undergo screening assessments and receive:
MRG003: 2.0 mg/kg IV on Day 1 every 3 weeks, starting ≥30 min after completion of the ICI infusion; infused over 60 ± 10 min (first cycle ≥60 min), extendable up to 120 min if a 60-min infusion is not tolerated.
ICI: Investigator's choice, including but not limited to camrelizumab, tislelizumab, or pembrolizumab; IV on Day 1 every 3 weeks, infused per product labeling.
Radiotherapy: Individualized conventionally fractionated radiotherapy or SBRT to the primary or metastatic lesions, approximately 50-60 Gy in 25-30 fractions (or a biologically equivalent regimen), started within the first two cycles. The investigator decides whether to withhold the ICI during radiotherapy.
Treatment discontinuation: Until clinical or radiological progression per RECIST v1.1, unacceptable toxicity, withdrawal of consent, or other protocol-defined discontinuation criteria, whichever occurs first.
- Conditions
- ESCC
- Being tested
- Becotatug vedotin (MRG003)
- Keywords
- Becotatug vedotin, ICIs, radiotherapy, ESCC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Becotatug vedotin (MRG003)Drug
Also called Immune checkpoint inhibitor, radiotherapy
- Becotatug vedotin (MRG003): 2.0 mg/kg, D1,Q3W, starting at least 30 minutes after completion of the ICI infusion.
- Immune checkpoint inhibitor: Investigator's choice, including but not limited to camrelizumab, tislelizumab, and pembrolizumab; Q3W, IV, Day 1, with infusion duration per the respective prescribing information.
- Multimodal radiotherapy: Initiated within the first 2 cycles of systemic therapy (no later than the end of Cycle 2), targeting the primary lesion and/or metastatic lesions. An individualized radiotherapy plan is delivered, using conventionally fractionated radiotherapy or SBRT, at approximately 50-60 Gy in 25-30 fractions (or a biologically equivalent dose/fractionation schedule). Investigators may appropriately adjust the timing, dose, and fractionation. Whether the ICI is withheld during radiotherapy is left to the investigator's discretion based on the patient's clinical condition.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Becotatug vedotin (MRG003): 2.0 mg/kg, D1,Q3W, starting at least 30 minutes after completion of the ICI infusion.
Immune checkpoint inhibitor: Investigator's choice, including but not limited to camrelizumab, tislelizumab, and pembrolizumab; Q3W, IV, Day 1, with infusion duration per the respective prescribing information.
Multimodal radiotherapy: Initiated within the first 2 cycles of systemic therapy (no later than the end of Cycle 2), targeting the primary lesion and/or metastatic lesions. An individualized radiotherapy plan is delivered, using conventionally fractionated radiotherapy or SBRT, at approximately 50-60 Gy in 25-30 fractions (or a biologically equivalent dose/fractionation schedule). Investigators may appropriately adjust the timing, dose, and fractionation. Whether the ICI is withheld during radiotherapy is left to the investigator's discretion based on the patient's clinical condition. Receives: Drug: Becotatug vedotin (MRG003) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
ORR is defined as the proportion of subjects achieving confirmed Complete Response (CR) or Partial Response (PR) as assessed by the investigator according to RECIST v1.1 and iRECIST criteria. ORR analysis will be based on the Full Analysis Set (FAS).
Measured: up to 2years
Secondary outcomes (5)
Disease Control Rate
defined as the proportion of subjects achieving confirmed Complete Response (CR), Partial Response (PR), or Stable Disease (SD) lasting for at least 6 weeks from the first dose, as assessed by the investigator according to RECIST v1.1 and iRECIST criteria. DCR will be estimated together with its exact 95% CI using the Clopper-Pearson method.
Measured: up to 2years
Progression-Free Survival
Progression Free Survival (PFS)s defined as the timefom enrollmentto the firstoccurence of disease progression or death from any cause. For subjectswithout observedprogression or death, PFS willbe censored at the time of the lastvalid and adequate assessment.FS analysis wilbe based on the FAS. Themedian PFS and its 95% C wll be estimated using theKaplan- Meier method, and progression-free survival curves will be generated.
Measured: up to 2years
Overall survival
Overall survival (OS) is defined as the time from the date of first dose of study treatment to the date of death from any cause. For subjects who are alive at the time of analysis or who are lost to follow-up, OS will be censored at the date of last known alive. Subjects with no post-baseline information will be censored at the date of first dose. OS will be estimated using the Kaplan-Meier method, and the median OS with its 95% CI will be calculated (with the 95% CI for the median derived using the Brookmeyer-Crowley method).
Measured: up to 2years
Duration of relief
For patients who have confirmed remission (as evaluated by RECIST v1.1 and iRECIST criteria, with PR or CR status), the time period between the first evidence of remission (PR or CR) and the first evidence of disease progression (PD) or death due to any cause. For subjects who did not show progression or death, the DOR will be censored at the last time of adequate tumor assessment.
Measured: up to 2years
Treatment Emergent Adverse Events (Safety and Tolerability）
Incidence of adverse events (AEs), serious adverse events (SAEs), treatment-related adverse events (TRAEs), and immune-related adverse events (irAEs); severity grading; and laboratory abnormalities, assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 6.0.
Measured: From the first dose of study treatment through 30 days after the last dose of study treatment (up to 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study start1 May 2026
- Primary completion31 May 2028 (estimated)
- Study completion30 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ESCCStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Becotatug vedotin in combination with immunotherapy and multimodality radiotherapy for esophageal squamous cell carcinoma in the second-line or later setting
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Bengbu Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hongwei Li, The First Affiliated Hospital of Bengbu Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07892833
- Sponsor's protocol ID
- [ 2026 ] KY041
- Acronym
- VISTA-ESCC
- Status last verified
- Oct 2026
- First submitted
- 16 Oct 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-Arm, Exploratory Clinical Study of Vebreltinib Antibody-Drug Conjugate (EGFR-ADC) in Combination With Investigator-Selected Immune Checkpoint Inhibitors and Multimodal Radiotherapy for Second-Line and Beyond Treatment of Advanced Esophageal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT07892833
- Acronym / sponsor ID
- VISTA-ESCC / [ 2026 ] KY041
- Conditions
- ESCC
- Keywords
- Becotatug vedotin, ICIs, radiotherapy, ESCC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Bengbu Medical UniversityUniversity, hospital or other
- Study start
- 1 May 2026 (actual)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 30 Apr 2029 (estimated)
- First posted
- 23 Oct 2026 (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.
This is a prospective, single-arm, exploratory, single-center clinical study designed to evaluate the efficacy and safety of becotatug vedotin (MRG003) in combination with an investigator's choice of immune checkpoint inhibitor (ICI) plus multimodal radiotherapy in patients with advanced esophageal squamous cell carcinoma (ESCC) in the second-line or later setting.
Treatment regimen for eligible subjects:
Becotatug vedotin (MRG003): 2.0 mg/kg, administered intravenously on Day 1 of each 21-day cycle (Q3W), starting at least 30 minutes after completion of the ICI infusion.
Immune checkpoint inhibitor: Investigator's choice, including but not limited to camrelizumab, tislelizumab, and pembrolizumab; Q3W, IV, Day 1, with infusion duration per the respective prescribing information.
Multimodal radiotherapy: Initiated within the first 2 cycles of systemic therapy (no later than the end of Cycle 2), targeting the primary lesion and/or metastatic lesions. An individualized radiotherapy plan is delivered, using conventionally fractionated radiotherapy or stereotactic body radiotherapy (SBRT), at approximately 50-60 Gy in 25-30 fractions (or a biologically equivalent dose/fractionation schedule). Investigators may appropriately adjust the timing, dose, and fractionation. Whether the ICI is withheld during radiotherapy is left to the investigator's discretion based on the patient's clinical condition.
Detailed description
This prospective, single-arm, exploratory, single-center study evaluates the efficacy and safety of becotatug vedotin (MRG003) plus an investigator's choice of immune checkpoint inhibitor (ICI) and multimodal radiotherapy in patients with previously treated advanced esophageal squamous cell carcinoma (ESCC).
Eligibility: Histologically confirmed recurrent, metastatic, or unresectable advanced ESCC; ECOG PS 0-1; failure of ≥1 prior standard first-line regimen (which may include PD-1/PD-L1 inhibitors, alone or in combination) due to progression or unacceptable toxicity; EGFR-positive (≥1+) by immunohistochemistry; ≥1 measurable lesion per RECIST v1.1; and able to tolerate radiotherapy. Because MRG003 is an EGFR-directed antibody-drug conjugate (EGFR-MMAE), IHC-confirmed EGFR positivity is required to ensure efficacy and avoid off-target toxicity.
Study design: Screening, treatment, and follow-up periods. During treatment, patients receive MRG003 with an investigator-selected PD-1/PD-L1 inhibitor or CTLA-4-containing ICI, chosen according to disease status, guideline recommendations, and prior data. Radiotherapy is started within the first two cycles (no later than the end of Cycle 2, before Cycle 3), targeting the primary or metastatic lesions, as conventionally fractionated radiotherapy or SBRT; timing, dose, and fractionation may be adjusted by the investigator.
After signing informed consent, eligible patients undergo screening assessments and receive:
MRG003: 2.0 mg/kg IV on Day 1 every 3 weeks, starting ≥30 min after completion of the ICI infusion; infused over 60 ± 10 min (first cycle ≥60 min), extendable up to 120 min if a 60-min infusion is not tolerated.
ICI: Investigator's choice, including but not limited to camrelizumab, tislelizumab, or pembrolizumab; IV on Day 1 every 3 weeks, infused per product labeling.
Radiotherapy: Individualized conventionally fractionated radiotherapy or SBRT to the primary or metastatic lesions, approximately 50-60 Gy in 25-30 fractions (or a biologically equivalent regimen), started within the first two cycles. The investigator decides whether to withhold the ICI during radiotherapy.
Treatment discontinuation: Until clinical or radiological progression per RECIST v1.1, unacceptable toxicity, withdrawal of consent, or other protocol-defined discontinuation criteria, whichever occurs first.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Becotatug vedotin in combination with immunotherapy and multimodality radiotherapy for esophageal squamous cell carcinoma in the second-line or later setting
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: Becotatug vedotin (MRG003)Becotatug vedotin (MRG003): 2.0 mg/kg, D1,Q3W, starting at least 30 minutes after completion of the ICI infusion. Immune checkpoint inhibitor: Investigator's choice, including but not limited to camrelizumab, tislelizumab, and pembrolizumab; Q3W, IV, Day 1, with infusion duration per the respective prescribing information. Multimodal radiotherapy: Initiated within the first 2 cycles of systemic therapy (no later than the end of Cycle 2), targeting the primary lesion and/or metastatic lesions. An individualized radiotherapy plan is delivered, using conventionally fractionated radiotherapy or SBRT, at approximately 50-60 Gy in 25-30 fractions (or a biologically equivalent dose/fractionation schedule). Investigators may appropriately adjust the timing, dose, and fractionation. Whether the ICI is withheld during radiotherapy is left to the investigator's discretion based on the patient's clinical condition. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patients voluntarily participated in the trial, fully informed consent, signed written informed consent, and had good compliance;
- Age of 18-80 years old (including the cut-off value), male or female;
- Recurrent/metastatic or unresectable advanced esophageal squamous cell carcinoma confirmed by pathology or histology;
- Failure of at least one previous standard therapy (including chemotherapy, PD-1 or PD-L1 inhibitors, etc.);
- At least one baseline extracranial measurable lesion, according to RECIST 1.1 criteria (≥10 mm in the greatest dimension on CT scan or ≥15 mm in the short dimension if the lesion is a lymph node), that had not received radiation therapy or had received previous local radiation therapy but was considered by the investigator to be reirradiated;
Key exclusion criteria (17 listed)
- The presence of symptomatic or untreated known brain metastases or other central nervous system metastases that were completely resected and/or demonstrated to be stable or improved after radiotherapy were not exclusion criteria, as long as they were stable on computed tomography (CT) for at least 4 weeks before screening, had no evidence of cerebral edema, and did not require glucocorticoids or anticonvulsants;
- The subjects had a malignancy other than esophageal squamous cell carcinoma within 5 years before enrollment. Note: Skin basal cell carcinoma, superficial bladder cancer, skin squamous cell carcinoma, or cervical cancer in situ were excluded. Or patients who had received curative treatment and had not relapsed within 5 years could participate in the trial;
- Known to be allergic to a drug or a drug component;
- Previous treatment interruption due to severe and/or life-threatening immune-related toxicity;
- NCI-CTCAE v5.0 grade of adverse events caused by previous antineoplastic therapy did not recover to ≤1 before enrollment (except alopecia or antineoplastic therapy-induced tolerable events according to investigator's opinion);
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 |
|---|---|---|
| Becotatug vedotin (MRG003)Also: Immune checkpoint inhibitor, radiotherapy1. Becotatug vedotin (MRG003): 2.0 mg/kg, D1,Q3W, starting at least 30 minutes after completion of the ICI infusion. 2. Immune checkpoint inhibitor: Investigator's choice, including but not limited to camrelizumab, tislelizumab, and pembrolizumab; Q3W, IV, Day 1, with infusion duration per the respective prescribing information. 3. Multimodal radiotherapy: Initiated within the first 2 cycles of systemic therapy (no later than the end of Cycle 2), targeting the primary lesion and/or metastatic lesions. An individualized radiotherapy plan is delivered, using conventionally fractionated radiotherapy or SBRT, at approximately 50-60 Gy in 25-30 fractions (or a biologically equivalent dose/fractionation schedule). Investigators may appropriately adjust the timing, dose, and fractionation. Whether the ICI is withheld during radiotherapy is left to the investigator's discretion based on the patient's clinical condition. | Drug | Experimental |
Primary outcome
Objective Response Rate
Time frame: up to 2years
ORR is defined as the proportion of subjects achieving confirmed Complete Response (CR) or Partial Response (PR) as assessed by the investigator according to RECIST v1.1 and iRECIST criteria. ORR analysis will be based on the Full Analysis Set (FAS).
5 secondary outcomes
Disease Control Rate
Time frame: up to 2years
Progression-Free Survival
Time frame: up to 2years
Overall survival
Time frame: up to 2years
Duration of relief
Time frame: up to 2years
Treatment Emergent Adverse Events (Safety and Tolerability）
Time frame: From the first dose of study treatment through 30 days after the last dose of study treatment (up to 2 years)
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 23 Oct 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Becotatug vedotin (MRG003) in people with ESCC, run by The First Affiliated Hospital of Bengbu 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 14 inclusion and 17 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 23 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 Hongwei Li, MD (+86-0552-3097010, hongweili@bbmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: up to 2years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Oct 2026.