Esophageal Squamous Cell CarcinomaPhase 2NCT07686926
Becotatug Vedotin Plus Tislelizumab and Low-Dose Lenvatinib for Advanced Esophageal Squamous Cell Carcinoma, Phase II
A Phase 2 study testing Becotatug Vedotin, Tislelizumab and Lenvatinib in people with Esophageal Squamous Cell Carcinoma, run by Tianjin Medical University Cancer Institute and Hospital.
Trial summary
Immunotherapy combined with chemotherapy has become the first-line standard of care for advanced esophageal squamous cell carcinoma (ESCC), significantly improving patient survival. However, with the widespread adoption of first-line immunotherapy, most patients eventually develop immune resistance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma
- What is being tested?
- Becotatug Vedotin, Tislelizumab and Lenvatinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 31 Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.Age ≥ 18 years, male or female. 2.Histopathologically or cytologically confirmed recurrent or metastatic esophageal squamous cell carcinoma.
- 3.Failed first-line or above standard systemic therapy for advanced disease. 4.Patients must be able to provide tumor specimens (paraffin blocks, paraffin-embedded sections, or fresh tissue sections) from primary or metastatic lesions for pathological testing. The most recent archived tumor tissue specimen may be used. If archived tissue is unavailable, a new biopsy is required.
- 5.ECOG PS 0-2. 6.Expected survival ≥ 3 months. 7.At least one measurable target lesion assessable by CT or MRI according to RECIST version 1.1 criteria.
- 8.Adequate organ and bone marrow function, as demonstrated by the following laboratory values:
- Bone marrow: Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L；Platelet count (PLT) ≥ 100×10⁹/L；Hemoglobin (HGB)≥90 g/L.
- Liver: Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)≤2.5×ULN; for patients with liver metastases, ALT and AST≤5×ULN.
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- Kidney: Creatinine clearance (Ccr) ≥ 50 mL/min (calculated using the Cockcroft-Gault formula).
- Coagulation: International normalized ratio (INR) ≤ 1.5 × ULN and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN (except for patients receiving therapeutic anticoagulation).
- Cardiac function: No severe cardiac dysfunction, with left ventricular ejection fraction (LVEF) ≥ 50%.
- 9.Female patients of childbearing potential must agree to use contraception during the study and for 6 months after the end of study participation, have a negative serum or urine pregnancy test within 7 days prior to study enrollment, and must not be breastfeeding. Male patients must agree to use contraception during the study and for 6 months after the end of study participation.
- 10.Patients must be able and willing to comply with the scheduled visits, treatment plans, laboratory tests, and other study-related procedures as outlined in the protocol.
- 11.Patients must be able to understand the study and voluntarily sign the informed consent form.
Who cannot join
- Prior malignancy within 5 years, except for carcinoma in situ, basal cell carcinoma, or other malignancies considered cured with negligible risk of recurrence.
- Known hypersensitivity to any component of the study regimen.
- High risk of gastrointestinal bleeding, esophageal fistula, or esophageal perforation.
- Untreated or unstable parenchymal brain metastases, spinal cord metastasis or compression, leptomeningeal disease, or meningeal metastases.
- Evidence of active infection, including:1）Hepatitis B (HBsAg positive with HBV DNA ≥ 2000 IU/mL, excluding drug-induced or other causes of hepatitis);2）Hepatitis C (anti-HCV antibody positive with HCV RNA above the lower limit of detection);3）Human immunodeficiency virus (HIV) infection;4）Uncontrolled active bacterial, viral, fungal, rickettsial, or parasitic infections that have not resolved prior to study drug administration.
- Third-space fluid that cannot be controlled by drainage (e.g., massive ascites, pleural effusion, pericardial effusion), or subjects requiring drainage to control third-space fluid within 14 days prior to first dose.
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- Any severe or uncontrolled systemic disease in the investigator's judgment.
- Poorly controlled cardiac disease, including:
- 1）Heart failure > New York Heart Association (NYHA) class II; 2）Unstable angina pectoris; 3）Myocardial infarction within 1 year; 4）Clinically significant supraventricular or ventricular arrhythmias requiring treatment; 5）Long QT syndrome, with QTcF > 450 ms (male) or QTcF > 470 ms (female). 9.History of primary immunodeficiency or active autoimmune disease, or current use of immunosuppressants or systemic corticosteroids (≥ 10 mg/day prednisone or equivalent) continuing within 2 weeks prior to enrollment.
- 10.History of or concomitant interstitial lung disease (ILD), radiation pneumonitis, severe chronic obstructive pulmonary disease (COPD), severe pulmonary insufficiency, or symptomatic bronchospasm.
- 11.Positive serum pregnancy test or breastfeeding females who do not agree to use adequate contraception during the study and for 6 months after the last dose of study drug.
- 12.History of organ transplantation, including allogeneic peripheral stem cell or bone marrow transplantation.
- 13.Peripheral neuropathy ≥ Grade 2 (per CTCAE version 5.0). 14.Prior receipt of any of the following treatments:
- Intravenous antibiotic therapy within 7 days prior to first dose.
- Investigational drug from another clinical trial within 4 weeks prior to first dose.
- Live attenuated vaccine within 4 weeks prior to first dose. Inactivated seasonal influenza vaccines or approved non-replicating COVID-19 vaccines are permitted.
- Systemic immunostimulatory agents (including but not limited to interferon, interleukin-2, etc.) within 4 weeks prior to first dose.
- Major surgical procedure (e.g., abdominal or thoracic surgery, excluding diagnostic puncture, infusion device placement, or gastrointestinal stent placement) within 4 weeks prior to first dose, or anticipation of major surgery not directed at the tumor during the study treatment period.
- 15.History of substance abuse (psychoactive drugs) that cannot be abstained from, or psychiatric disorders.
- 16.Concurrent participation in another interventional clinical study. 17.Any other condition that, in the investigator's judgment, makes the subject unsuitable for participation in this clinical trial.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Becotatug Vedotin Combined With Tislelizumab and Low-Dose Lenvatinib in Patients With Advanced Esophageal Squamous Cell Carcinoma Who Failed First-Line Therapy: A Phase II Exploratory Study
Immunotherapy combined with chemotherapy has become the first-line standard of care for advanced esophageal squamous cell carcinoma (ESCC), significantly improving patient survival. However, with the widespread adoption of first-line immunotherapy, most patients eventually develop immune resistance. After first-line treatment failure, there is currently no established standard effective therapy for second-line ESCC. Therefore, more effective and safer treatment options are urgently needed for second-line advanced ESCC.
This is a prospective, single-arm, single-center, open-label, Phase II clinical study aiming to evaluate the efficacy and safety of Becotatug Vedotin combined with Tislelizumab and low-dose Lenvatinib in patients with advanced ESCC who have failed first-line therapy. Eligible patients will receive Becotatug Vedotin combined with Tislelizumab and low-dose Lenvatinib. The primary endpoint is objective response rate (ORR) assessed per RECIST v1.1. Secondary endpoints include progression-free survival (PFS), disease control rate (DCR), duration of response (DOR), overall survival (OS), and safety.
Read the detailed description
The study consists of two phases: a dose-run-in phase and a dose-expansion phase.
Phase 1 (Dose-Run-In Phase): After signing informed consent, 6 eligible patients will receive Becotatug Vedotin combined with Tislelizumab and low-dose Lenvatinib during the safety run-in period to evaluate the safety and tolerability of the regimen: Becotatug Vedotin (2.0mg/kg, iv, d1, q3w, for 4-6 cycles) combined with Tislelizumab (200mg, iv, d1, q3w) and low-dose Lenvatinib (4 mg, po，once daily at a fixed time). If no more than 1 patient among the 6 treated patients experiences a dose-limiting toxicity (DLT) and no unexpected unacceptable serious adverse events occur, the study will proceed to Phase 2.
Phase 2 (Dose-Expansion Phase): Eligible patients will receive the same combination regimen of Becotatug Vedotin, Tislelizumab, and low-dose Lenvatinib as in Phase 1. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of informed consent, death, pregnancy, investigator's decision to discontinue treatment, or study termination, whichever occurs first.
- Conditions
- Esophageal Squamous Cell Carcinoma
- Being tested
- Becotatug Vedotin, Tislelizumab, Lenvatinib
- Medical subject headings
- Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Becotatug VedotinDrug
Becotatug Vedotin 2.0 mg/kg administered as an intravenous infusion on Day 1 of each 21-day cycle for 4 to 6 cycles.
TislelizumabDrug
Tislelizumab 200 mg administered as an intravenous infusion on Day 1 of each 21-day cycle, continued for up to 35 cycles (approximately 2 years), or until disease progression, unacceptable toxicity, withdrawal of informed consent, death, pregnancy, investigator decision to discontinue, or study termination, whichever occurs first.
LenvatinibDrug
Low-Dose Lenvatinib 4 mg administered orally at a fixed time once daily, continued until disease progression, unacceptable toxicity, withdrawal of informed consent, death, pregnancy, investigator decision to discontinue, or study termination, whichever occurs first.
| Study group | Role | What they receive |
|---|---|---|
| Becotatug Vedotin Combined with Tislelizumab and Low-Dose Lenvatinib | Experimental | Participants in this single arm receive Becotatug Vedotin (2.0mg/kg, iv, D1, Q3W, 4 to 6 cycles) in combination with Tislelizumab (200 mg, iv, D1 Q3W, continued for up to 35 cycles [approximately 2 years]) and Low-Dose Lenvatinib (4 mg, orally, once daily at a fixed time. Treatment continues until disease progression, unacceptable toxicity, withdrawal of informed consent, death, pregnancy, investigator decision to discontinue, or study termination, whichever occurs first. ).The study consists of a safety run-in phase (approximately 6 participants) followed by an expansion phase (to a total of approximately 36 participants) . Receives: Drug: Becotatug Vedotin; Drug: Tislelizumab; Drug: Lenvatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Objective response rate is defined as the proportion of patients who achieve complete response (CR) or partial response (PR) as assessed by the investigator per RECIST version 1.1.
Measured: From start of treatment until disease progression, assessed up to 24 months
Secondary outcomes (5)
Progression-Free Survival (PFS)
Progression-free survival is defined as the time from the first dose of study treatment to the first documented disease progression per RECIST version 1.1 or death from any cause, whichever occurs first.
Measured: From start of treatment to disease progression or death, assessed up to 36 months.
Overall Survival (OS)
Overall survival is defined as the time from the first dose of study treatment to death from any cause.
Measured: From start of treatment to death, assessed up to 36 months.
Disease Control Rate (DCR)
Disease control rate is defined as the proportion of patients who achieve complete response (CR), partial response (PR), or stable disease (SD) as assessed by the investigator per RECIST version 1.1.
Measured: From start of treatment until disease progression, assessed up to 24 months.
Duration of Response (DOR)
Duration of response is defined as the time from the first documented objective response (CR or PR) to the first documented disease progression per RECIST version 1.1 or death from any cause, whichever occurs first.
Measured: From first documented response to disease progression or death, assessed up to 24 months.
Safety and Tolerability
Safety and tolerability will be assessed by the incidence, nature, and severity of adverse events (AEs) and serious adverse events (SAEs) according to NCI CTCAE version 5.0.
Measured: From first dose of study drug until 30 days after the last dose, assessed up to 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07686926
- Sponsor's protocol ID
- ESCC-BecoTisLen-E20260709
- Status last verified
- Jun 2026
- First submitted
- 30 Jun 2026
- Last updated
- 16 Jul 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 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Becotatug Vedotin Combined With Tislelizumab and Low-Dose Lenvatinib in Patients With Advanced Esophageal Squamous Cell Carcinoma Who Failed First-Line Therapy: A Phase II Exploratory Study
- ClinicalTrials.gov ID
- NCT07686926
- Acronym / sponsor ID
- ESCC-BecoTisLen-E20260709
- Conditions
- Esophageal Squamous Cell Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 7 Jul 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.
Immunotherapy combined with chemotherapy has become the first-line standard of care for advanced esophageal squamous cell carcinoma (ESCC), significantly improving patient survival. However, with the widespread adoption of first-line immunotherapy, most patients eventually develop immune resistance. After first-line treatment failure, there is currently no established standard effective therapy for second-line ESCC. Therefore, more effective and safer treatment options are urgently needed for second-line advanced ESCC.
This is a prospective, single-arm, single-center, open-label, Phase II clinical study aiming to evaluate the efficacy and safety of Becotatug Vedotin combined with Tislelizumab and low-dose Lenvatinib in patients with advanced ESCC who have failed first-line therapy. Eligible patients will receive Becotatug Vedotin combined with Tislelizumab and low-dose Lenvatinib. The primary endpoint is objective response rate (ORR) assessed per RECIST v1.1. Secondary endpoints include progression-free survival (PFS), disease control rate (DCR), duration of response (DOR), overall survival (OS), and safety.
Detailed description
The study consists of two phases: a dose-run-in phase and a dose-expansion phase.
Phase 1 (Dose-Run-In Phase): After signing informed consent, 6 eligible patients will receive Becotatug Vedotin combined with Tislelizumab and low-dose Lenvatinib during the safety run-in period to evaluate the safety and tolerability of the regimen: Becotatug Vedotin (2.0mg/kg, iv, d1, q3w, for 4-6 cycles) combined with Tislelizumab (200mg, iv, d1, q3w) and low-dose Lenvatinib (4 mg, po，once daily at a fixed time). If no more than 1 patient among the 6 treated patients experiences a dose-limiting toxicity (DLT) and no unexpected unacceptable serious adverse events occur, the study will proceed to Phase 2.
Phase 2 (Dose-Expansion Phase): Eligible patients will receive the same combination regimen of Becotatug Vedotin, Tislelizumab, and low-dose Lenvatinib as in Phase 1. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of informed consent, death, pregnancy, investigator's decision to discontinue treatment, or study termination, whichever occurs first.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Becotatug Vedotin Combined with Tislelizumab and Low-Dose Lenvatinib | Experimental | Drug: Becotatug Vedotin, Drug: Tislelizumab, Drug: LenvatinibParticipants in this single arm receive Becotatug Vedotin (2.0mg/kg, iv, D1, Q3W, 4 to 6 cycles) in combination with Tislelizumab (200 mg, iv, D1 Q3W, continued for up to 35 cycles [approximately 2 years]) and Low-Dose Lenvatinib (4 mg, orally, once daily at a fixed time. Treatment continues until disease progression, unacceptable toxicity, withdrawal of informed consent, death, pregnancy, investigator decision to discontinue, or study termination, whichever occurs first. ).The study consists of a safety run-in phase (approximately 6 participants) followed by an expansion phase (to a total of approximately 36 participants) . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 1.Age ≥ 18 years, male or female. 2.Histopathologically or cytologically confirmed recurrent or metastatic esophageal squamous cell carcinoma.
- 3.Failed first-line or above standard systemic therapy for advanced disease. 4.Patients must be able to provide tumor specimens (paraffin blocks, paraffin-embedded sections, or fresh tissue sections) from primary or metastatic lesions for pathological testing. The most recent archived tumor tissue specimen may be used. If archived tissue is unavailable, a new biopsy is required.
- 5.ECOG PS 0-2. 6.Expected survival ≥ 3 months. 7.At least one measurable target lesion assessable by CT or MRI according to RECIST version 1.1 criteria.
- 8.Adequate organ and bone marrow function, as demonstrated by the following laboratory values:
- Bone marrow: Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L；Platelet count (PLT) ≥ 100×10⁹/L；Hemoglobin (HGB)≥90 g/L.
Key exclusion criteria (20 listed)
- Prior malignancy within 5 years, except for carcinoma in situ, basal cell carcinoma, or other malignancies considered cured with negligible risk of recurrence.
- Known hypersensitivity to any component of the study regimen.
- High risk of gastrointestinal bleeding, esophageal fistula, or esophageal perforation.
- Untreated or unstable parenchymal brain metastases, spinal cord metastasis or compression, leptomeningeal disease, or meningeal metastases.
- Evidence of active infection, including:1）Hepatitis B (HBsAg positive with HBV DNA ≥ 2000 IU/mL, excluding drug-induced or other causes of hepatitis);2）Hepatitis C (anti-HCV antibody positive with HCV RNA above the lower limit of detection);3）Human immunodeficiency virus (HIV) infection;4）Uncontrolled active bacterial, viral, fungal, rickettsial, or parasitic infections that have not resolved prior to study drug administration.
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 VedotinBecotatug Vedotin 2.0 mg/kg administered as an intravenous infusion on Day 1 of each 21-day cycle for 4 to 6 cycles. | Drug | Becotatug Vedotin Combined with Tislelizumab and Low-Dose Lenvatinib |
| TislelizumabTislelizumab 200 mg administered as an intravenous infusion on Day 1 of each 21-day cycle, continued for up to 35 cycles (approximately 2 years), or until disease progression, unacceptable toxicity, withdrawal of informed consent, death, pregnancy, investigator decision to discontinue, or study termination, whichever occurs first. | Drug | Becotatug Vedotin Combined with Tislelizumab and Low-Dose Lenvatinib |
| LenvatinibLow-Dose Lenvatinib 4 mg administered orally at a fixed time once daily, continued until disease progression, unacceptable toxicity, withdrawal of informed consent, death, pregnancy, investigator decision to discontinue, or study termination, whichever occurs first. | Drug | Becotatug Vedotin Combined with Tislelizumab and Low-Dose Lenvatinib |
Primary outcome
Objective Response Rate (ORR)
Time frame: From start of treatment until disease progression, assessed up to 24 months
Objective response rate is defined as the proportion of patients who achieve complete response (CR) or partial response (PR) as assessed by the investigator per RECIST version 1.1.
5 secondary outcomes
Progression-Free Survival (PFS)
Time frame: From start of treatment to disease progression or death, assessed up to 36 months.
Overall Survival (OS)
Time frame: From start of treatment to death, assessed up to 36 months.
Disease Control Rate (DCR)
Time frame: From start of treatment until disease progression, assessed up to 24 months.
Duration of Response (DOR)
Time frame: From first documented response to disease progression or death, assessed up to 24 months.
Safety and Tolerability
Time frame: From first dose of study drug until 30 days after the last dose, assessed up to 24 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 16 Jul 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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Becotatug Vedotin, Tislelizumab and Lenvatinib in people with Esophageal Squamous Cell Carcinoma, run by Tianjin Medical University Cancer Institute and Hospital.
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 12 inclusion and 20 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: opening soon, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Rui Liu (+86 13602139003, liurui9003@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: From start of treatment until disease progression, assessed up to 24 months). 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 16 Jul 2026.