Esophageal Squamous CarcinomaPhase 1/2NCT06055153
DV Combined With PD-1 and Platinum-based First-line Treatment in Patients With HER2 IHC2+/3+ ESCC
A Phase 1/2 study testing RC48+PD-1+platinum-based in people with Esophageal Squamous Carcinoma and HER-2 Protein Overexpression, run by Changhai Hospital.
Trial summary
This is a single-arm, exploratory clinical study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Squamous Carcinoma, HER-2 Protein Overexpression
- What is being tested?
- RC48+PD-1+platinum-based
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2023to 30 Apr 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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
- ≥18 years old, male or female;
- Patients with locally advanced unresectable, recurrent, or metastatic esophageal cancer were confirmed by imaging examination, and esophageal squamous cell carcinoma was confirmed by histopathology.
- For those who have received radical therapy and (new) adjuvant therapy, the time of first recurrence or disease progression is greater than 6 months after the end of the last treatment;
- The HER2 immunohistochemical test was 2+ or 3+;
- According to the solid tumor Efficacy Evaluation Criteria (RECIST), there should be at least one target lesion that has not received local treatment such as radiotherapy (target lesion located in the previous radiotherapy area can also be selected as a target lesion if it is confirmed to have progressed and meets the RECIST criteria);
- ECOG score: 0~1;
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- Expected survival≥12 weeks;
- The function of vital organs met the following requirements (no blood components and cell growth factors were used in the first 2 weeks of enrollment):
- Absolute neutrophil count ≥1.5×109/L Platelet ≥100 × 109/L Hemoglobin ≥90g/L Serum albumin ≥28g/L Bilirubin≤ 1.5 × ULN In the absence of liver metastasis, ALT and AST≤2.5 × ULN; in the presence of liver metastasis, ALT and AST≤5 × ULN Creatinine clearance ≥50ml/min(Cockcroft-Gault); Left ventricular ejection fraction (LVEF) was ≥50% by echocardiography;
- Fertile female subjects should undergo a urine or serum pregnancy test that proves negative within 72 hours prior to receiving the initial study drug administration and be willing to use an effective method of contraception during the trial period until 3 months after the last dose. For male subjects whose partner is a woman of childbearing age, effective contraception should be used during the trial and within 3 months after the last dose;
- The subjects voluntarily joined the study, signed informed consent, had good compliance, and cooperated with follow-up.
Who cannot join
- Other malignancies have been diagnosed within 3 years prior to the first dose, except for effectively treated basal cell carcinoma of the skin, clinical cell carcinoma of the skin, and/or effectively resected cervical and/or breast cancer in situ;
- There is central nervous system metastasis treatment within one month after stabilization;
- Have any active autoimmune disease or a history of autoimmune disease (such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (can be included after normal hormone replacement therapy); Patients with vitiligo or who had complete remission of asthma in childhood and did not require any intervention as adults could be included, but patients with asthma requiring medical intervention with bronchodilators could not be included;
- suffering from uncontrolled cardiac clinical symptoms or diseases, such as NYHA class II or above heart failure; Unstable angina pectoris; Myocardial infarction within 1 year; Patients with clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention;
- Active infection or unexplained fever >38.5℃ occurred during screening or before the first administration of the drug (as determined by the investigator, the subject's fever due to the tumor could be enrolled);
- Known history or evidence of interstitial lung disease or active non-infectious pneumonia;
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- congenital or acquired immune deficiency (such as HIV infection), active hepatitis B (HBV-DNA≥104/L copy number /ml) or hepatitis C (hepatitis C antibody positive and HCV-RNA higher than the lower detection limit of analytical methods);
- Known allergic reactions, hypersensitivities or contraindications to macromolecular protein preparations, or to platinum or any component used in preparations there of;
- Subjects requiring systemic therapy with corticosteroids (>10mg/ day efficacy dose of prednisone) or other immunosuppressants within 14 days prior to initial drug use. In the absence of active autoimmune disease, inhaled or topical steroid and adrenocortical hormone replacement at a therapeutic dose of >10mg/ day of prednisone are permitted;
- Participate in other clinical studies;
- Have received live vaccine within 4 weeks prior to the first administration of the drug, and are allowed to receive inactivated virus vaccine for seasonal influenza injection, but are not allowed to receive live attenuated influenza vaccine for nasal administration;
- Pregnant or lactating women;
- In the investigator's judgment, the subject has other factors that may lead to the forced termination of the study, such as other serious medical conditions (including mental illness) requiring co-treatment, serious abnormalities in laboratory test values, or family or social factors that may affect the subject's safety or the circumstances of the trial data collection.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: DV Combined With PD-1 and Platinum-based First-line Treatment in Patients With Locally Advanced or Metastatic HER2 IHC2+/3+ Esophageal Squamous Cell Carcinoma
This is a single-arm, exploratory clinical study.
Read the detailed description
This is a single-arm, exploratory clinical study. Aim to explore the safety and efficacy of Vedicetuzumab combined with an immune checkpoint inhibitor (carrellizumab) and platinum-based first-line treatment for locally advanced/metastatic HER2 overexpression (IHC 2+/3+) esophageal squamous cell carcinoma.
- Being tested
- RC48+PD-1+platinum-based
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RC48+PD-1+platinum-basedDrug
Also called Disitamab Vedotin+PD-1+platinum-based
Phase I: Three subjects with HER2 overexpression (IHC 2+/3+) were initially enrolled. If dose-limiting toxicity (DLT) was observed in two of the three subjects, the study was continued from dose 1 to dose 2. If ≤1 DLT is observed in 3 subjects, continue to enroll 3 patients, and if ≤2 DLT is observed in 6 subjects, proceed to the second phase. If > 2 cases of DLT are observed in 6 subjects, adjust to dose 2 for phase 2.
Dose 1: RC48 2.5mg/kg, d1, once every 3 weeks; Camrelizumab 200mg, d1 once every 3 weeks; Platinum: Cisplatin 75mg/m2(or nedaplatin 75mg/m2), d1, once every 3 weeks
Dose 2: RC48 2.0mg/kg, d1, once every 3 weeks; Camrelizumab 200mg, d1 once every 3 weeks; Platinum: Cisplatin 75mg/m2(or nedaplatin 75mg/m2), d1, once every 3 weeks
The second stage: sample size expansion stage. RP2D obtained at stage 1 continues to be enrolled in up to 20 patients until disease progression or intolerable toxicity occurs.
| Study group | Role | What they receive |
|---|---|---|
| RC48+PD-1+platinum-based | Experimental | Dose 1: RC48 2.5mg/kg intravenous infusion, d1 once every 3 weeks;
Camrelizumab dose: 200mg, intravenous infusion 30-60min, d1 once every 3 weeks;
Platinum (cisplatin or nedaplatin) : Cisplatin 75mg/m2, added into 500ml 0.9% sodium chloride injection for infusion, hydration and alkalization of -1d, d1, d2, once every 3 weeks; Nedaplatin 75mg/m2 was added to 500ml 0.9% sodium chloride injection, once every 3 weeks.
Dose 2: rc48 2.0mg/kg, d1, once every 3 weeks; Camrelizumab 200mg, d1 once every 3 weeks; Platinum: Cisplatin 75mg/m2(or nedaplatin 75mg/m2), d1, once every 3 weeks Receives: Drug: RC48+PD-1+platinum-based |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase II recommended dose (RP2D)
Defined as maximum tolerated dose or maximum administration dose.
Measured: Up to 28 days
Progression-Free Survival (PFS)
The time between the start of treatment and the onset of disease progression or death
Measured: Up to 2 years
Secondary outcomes (1)
objective response rate (ORR)
The percentage of patients whose tumors have shrunk to a certain amount and remain there for a certain amount of time, including complete response (CR) and partial response (PR) cases
Measured: 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 posted26 Sep 2023
- Study start30 Sep 2023 (estimated)
- Primary completion28 Feb 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Squamous CarcinomaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06055153
- Sponsor's protocol ID
- CHEC2023-167
- Status last verified
- Aug 2023
- First submitted
- 30 Aug 2023
- Last updated
- 26 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DV Combined With PD-1 and Platinum-based First-line Treatment in Patients With Locally Advanced or Metastatic HER2 IHC2+/3+ Esophageal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT06055153
- Acronym / sponsor ID
- CHEC2023-167
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 30 Sep 2023 (estimated)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 26 Sep 2023 (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 single-arm, exploratory clinical study.
Detailed description
This is a single-arm, exploratory clinical study. Aim to explore the safety and efficacy of Vedicetuzumab combined with an immune checkpoint inhibitor (carrellizumab) and platinum-based first-line treatment for locally advanced/metastatic HER2 overexpression (IHC 2+/3+) esophageal squamous cell carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RC48+PD-1+platinum-based | Experimental | Drug: RC48+PD-1+platinum-basedDose 1: RC48 2.5mg/kg intravenous infusion, d1 once every 3 weeks; Camrelizumab dose: 200mg, intravenous infusion 30-60min, d1 once every 3 weeks; Platinum (cisplatin or nedaplatin) : Cisplatin 75mg/m2, added into 500ml 0.9% sodium chloride injection for infusion, hydration and alkalization of -1d, d1, d2, once every 3 weeks; Nedaplatin 75mg/m2 was added to 500ml 0.9% sodium chloride injection, once every 3 weeks. Dose 2: rc48 2.0mg/kg, d1, once every 3 weeks; Camrelizumab 200mg, d1 once every 3 weeks; Platinum: Cisplatin 75mg/m2(or nedaplatin 75mg/m2), d1, once every 3 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- ≥18 years old, male or female;
- Patients with locally advanced unresectable, recurrent, or metastatic esophageal cancer were confirmed by imaging examination, and esophageal squamous cell carcinoma was confirmed by histopathology.
- For those who have received radical therapy and (new) adjuvant therapy, the time of first recurrence or disease progression is greater than 6 months after the end of the last treatment;
- The HER2 immunohistochemical test was 2+ or 3+;
- According to the solid tumor Efficacy Evaluation Criteria (RECIST), there should be at least one target lesion that has not received local treatment such as radiotherapy (target lesion located in the previous radiotherapy area can also be selected as a target lesion if it is confirmed to have progressed and meets the RECIST criteria);
Key exclusion criteria (13 listed)
- Other malignancies have been diagnosed within 3 years prior to the first dose, except for effectively treated basal cell carcinoma of the skin, clinical cell carcinoma of the skin, and/or effectively resected cervical and/or breast cancer in situ;
- There is central nervous system metastasis treatment within one month after stabilization;
- Have any active autoimmune disease or a history of autoimmune disease (such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (can be included after normal hormone replacement therapy); Patients with vitiligo or who had complete remission of asthma in childhood and did not require any intervention as adults could be included, but patients with asthma requiring medical intervention with bronchodilators could not be included;
- suffering from uncontrolled cardiac clinical symptoms or diseases, such as NYHA class II or above heart failure; Unstable angina pectoris; Myocardial infarction within 1 year; Patients with clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention;
- Active infection or unexplained fever >38.5℃ occurred during screening or before the first administration of the drug (as determined by the investigator, the subject's fever due to the tumor could be enrolled);
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 |
|---|---|---|
| RC48+PD-1+platinum-basedAlso: Disitamab Vedotin+PD-1+platinum-basedPhase I: Three subjects with HER2 overexpression (IHC 2+/3+) were initially enrolled. If dose-limiting toxicity (DLT) was observed in two of the three subjects, the study was continued from dose 1 to dose 2. If ≤1 DLT is observed in 3 subjects, continue to enroll 3 patients, and if ≤2 DLT is observed in 6 subjects, proceed to the second phase. If > 2 cases of DLT are observed in 6 subjects, adjust to dose 2 for phase 2. Dose 1: RC48 2.5mg/kg, d1, once every 3 weeks; Camrelizumab 200mg, d1 once every 3 weeks; Platinum: Cisplatin 75mg/m2(or nedaplatin 75mg/m2), d1, once every 3 weeks Dose 2: RC48 2.0mg/kg, d1, once every 3 weeks; Camrelizumab 200mg, d1 once every 3 weeks; Platinum: Cisplatin 75mg/m2(or nedaplatin 75mg/m2), d1, once every 3 weeks The second stage: sample size expansion stage. RP2D obtained at stage 1 continues to be enrolled in up to 20 patients until disease progression or intolerable toxicity occurs. | Drug | RC48+PD-1+platinum-based |
Primary outcome
Phase II recommended dose (RP2D)
Time frame: Up to 28 days
Defined as maximum tolerated dose or maximum administration dose.
Progression-Free Survival (PFS)
Time frame: Up to 2 years
The time between the start of treatment and the onset of disease progression or death
1 secondary outcome
objective response rate (ORR)
Time frame: Up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
- 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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing RC48+PD-1+platinum-based in people with Esophageal Squamous Carcinoma and HER-2 Protein Overexpression, run by Changhai 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 11 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 26 Sep 2023. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xianbao Zhan, Doctor (862131162338, zhanxianbao@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase II recommended dose (RP2D) (time frame: Up to 28 days). 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?
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 26 Sep 2023; AzTrials last refreshed its copy on 31 Oct 2026.