Gastric CancerPhase 2NCT05627414
Conversion Therapy of Disitamab Vedotin Combined With Sintilimab and S-1 in HER2 Overexpression Gastric Cancer
A Phase 2 study testing Disitamab Vedotin, Sintilimab and S-1 in people with Gastric Cancer, run by Tianjin Medical University Cancer Institute and Hospital.
Trial summary
This is a phase II, one-arm study, which is aiming to evaluate the feasibility of combination of Disitamab Vedotin, Sintilimab and S-1 as conversion therapy in patients with HER2 overexpression unresectable gastric cancer . Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Disitamab Vedotin, Sintilimab and S-1
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2023to 1 Jan 2025
- Phase
- Phase 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1) Volunteer to take part in the study ;
- 2) Age 18~70 (including 70), male or female;
- 3) Gastric cancer or adenocarcinoma of gastroesophageal junction confirmed by histology and/or cytology;
- 4) Has a single initial unresectable factor. For example, peritoneal metastasis (P1),Intraperitoneal free cancer cells positive (CY1), Paraaortic lymph node metastasis, liver metastasis (≤ 3 lesions, and ≤ 5 cm for a single lesion), ovarian metastasis;
- 5) Have not received systematic treatment;
- 6) The HER2 immunohistochemistry (IHC) test result is IHC 3+or 2+, and the previous test results of the subject (confirmed by the investigator) are acceptable;
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- 7) At least one assessable lesion (RECIST 1.1 );
- 8) Expected survival time ≥ 6 months;
- 9) ECOG 0-1;
- 10) Major organs are functioning normally；
Who cannot join
- 1) Have a history of malignant tumors other than gastric cancer, except for the following two cases:
- The patient has received possible curative treatment and there is no evidence of the disease within 5 years;
- The resected skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ and other carcinoma in situ were successfully received;
- 2) Suffering from diseases that affect the absorption, distribution, metabolism or clearance of the study drug (such as severe vomiting, chronic diarrhea, intestinal obstruction, absorption disorder, etc.);
- 3) Have received allogeneic stem cells or solid organ transplantation in the past;
- 4) Patients who have received other anti-tumor systemic therapy in the past (including traditional Chinese medicine with anti-tumor indications), and have been less than 4 weeks from the completion of treatment to the administration of this study, or the adverse events caused by previous treatment have not recovered to ≤ CTCAE level 1 (except hair loss and pigmentation);
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- 5) Previous or current congenital or acquired immunodeficiency disease;
- 6) Active or previously recorded autoimmune diseases or inflammatory diseases (including but not limited to: autoimmune hepatitis, interstitial pneumonia, inflammatory bowel disease, systemic lupus erythematosus, vasculitis, uveitis, hypophysitis, hyperthyroidism or hypothyroidism, asthma requiring bronchodilators, etc.), vitiligo or asthma that has completely alleviated in childhood, Those who do not need any intervention after adulthood can be included;
- 7) Systemic immunosuppressive drugs were used within 2 weeks before enrollment, or were expected to be required during the study, except for the following:
- Corticosteroids for intranasal, inhalation, external or local injection (such as intra-articular injection);
- The dose of prednisone or other equivalent systemic corticosteroids does not exceed 10 mg/day;
- Preventive use of corticosteroids for hypersensitivity;
- 8) Allergic to the study drug;
- 9) Thrombosis or thromboembolism events occurred in the past 6 months, such as stroke and/or transient ischemic attack, deep vein thrombosis, pulmonary embolism, etc;
- 10) Patients at risk for severe bleeding；
- 11) Cardiovascular diseases with significant clinical significance;
- 12) Other significant clinical and laboratory abnormalities, which the researchers think affect the safety evaluation;
- 13) Serious infection in active period or poorly controlled clinically;
- 14) Not recovered from the operation;
- 15) Pregnant or lactating women, and women or men with fertility who are unwilling or unable to take effective contraceptive measures;
- 16) Other situations that the investigator thinks are not suitable for inclusion.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Clinical Study on the Efficacy and Safety of Disitamab Vedotin Combined With Sintilimab and S-1 in the Conversion Treatment of HER2 Overexpression Unresectable Gastric Cancer
This is a phase II, one-arm study, which is aiming to evaluate the feasibility of combination of Disitamab Vedotin, Sintilimab and S-1 as conversion therapy in patients with HER2 overexpression unresectable gastric cancer .
Read the detailed description
In this study, 30 HER2 overexpression unresectable gastric cancer patients will enrolle and treate with Disitamab Vedotin, Sintilimab and S-1. During the study period, imaging examinations were conducted every 6-12 weeks to evaluate the tumor and whether it reached the operable standard. The scheme and duration of postoperative adjuvant treatment were determined by the investigator according to the patient's conditions (Sintilimab was recommended to be maintained for 1 year, and other drugs were increased or decreased according to the patient's conditions). During the study, safety evaluation and effectiveness evaluation will be conducted.
- Conditions
- Gastric Cancer
- Being tested
- Disitamab Vedotin, Sintilimab, S-1, Intraperitoneal chemotherapy with paclitaxel
- Keywords
- Conversion therapy, Disitamab Vedotin, HER2 overexpression
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Disitamab VedotinDrug
Also called RC48
2.5mg/kg，IV，Q3W
SintilimabDrug
Also called TYVYT
200 mg，IV，Q3W
S-1Drug
Also called Tegafur，Gimeracil and Oteracil Potassium Capsules
40~60mg / m2, bid, d1-14, repeated every 3 weeks.
Intraperitoneal chemotherapy with paclitaxelProcedure or surgery
Also called Paclitaxel (PTX)
Paclitaxel (PTX) was used with a dose of 60mg / m2, Q3W. （Only for patients with peritoneal metastases）
| Study group | Role | What they receive |
|---|---|---|
| Disitamab Vedotin Combined With Sintilimab and S-1 | Experimental | 30 HER2 overexpression unresectable gastric cancer patients will enrolle and treate with Disitamab Vedotin, Sintilimab and S-1. During the study period, imaging examinations were conducted every 6-12 weeks to evaluate the tumor and whether it reached the operable standard. The scheme and duration of postoperative adjuvant treatment were determined by the investigator according to the patient's conditions (Sintilimab was recommended to be maintained for 1 year, and other drugs were increased or decreased according to the patient's conditions). Receives: Drug: Disitamab Vedotin; Drug: Sintilimab; Drug: S-1; Procedure: Intraperitoneal chemotherapy with paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
R0 resection rate
The proportion of patients who underwent R0 surgery among all patients.
Measured: 1 year
Secondary outcomes (4)
objective response rate (ORR)
The proportion of patients who achieved patial response and complete reponse per RECIST version 1.1.
Measured: up to one year
overall survival (OS)
median OS or OS rate
Measured: From the first dose to death from any cause, up to two years.
Recurrence free survival（RFS）
median RFS or RFS rate
Measured: From the first dose to recurrence or death from any cause, up to two years.
safety profile
The grade and proportion of adverse events, treatment related adverse events, immune-related adverse events (irAEs), serious adverse events, and perioperative complications, etc.
Measured: up to 30 days after last treatment administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2022
- Study start1 Jan 2023 (estimated)
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Han Liang, Master, Principal investigator, ianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05627414
- Sponsor's protocol ID
- E20221046
- Status last verified
- Nov 2022
- First submitted
- 17 Nov 2022
- Last updated
- 25 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Efficacy and Safety of Disitamab Vedotin Combined With Sintilimab and S-1 in the Conversion Treatment of HER2 Overexpression Unresectable Gastric Cancer
- ClinicalTrials.gov ID
- NCT05627414
- Acronym / sponsor ID
- E20221046
- Conditions
- Gastric Cancer
- Keywords
- Conversion therapy, Disitamab Vedotin, HER2 overexpression
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 25 Nov 2022 (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 phase II, one-arm study, which is aiming to evaluate the feasibility of combination of Disitamab Vedotin, Sintilimab and S-1 as conversion therapy in patients with HER2 overexpression unresectable gastric cancer .
Detailed description
In this study, 30 HER2 overexpression unresectable gastric cancer patients will enrolle and treate with Disitamab Vedotin, Sintilimab and S-1. During the study period, imaging examinations were conducted every 6-12 weeks to evaluate the tumor and whether it reached the operable standard. The scheme and duration of postoperative adjuvant treatment were determined by the investigator according to the patient's conditions (Sintilimab was recommended to be maintained for 1 year, and other drugs were increased or decreased according to the patient's conditions). During the study, safety evaluation and effectiveness evaluation will be conducted.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Disitamab Vedotin Combined With Sintilimab and S-1 | Experimental | Drug: Disitamab Vedotin, Drug: Sintilimab, Drug: S-1, Procedure: Intraperitoneal chemotherapy with paclitaxel30 HER2 overexpression unresectable gastric cancer patients will enrolle and treate with Disitamab Vedotin, Sintilimab and S-1. During the study period, imaging examinations were conducted every 6-12 weeks to evaluate the tumor and whether it reached the operable standard. The scheme and duration of postoperative adjuvant treatment were determined by the investigator according to the patient's conditions (Sintilimab was recommended to be maintained for 1 year, and other drugs were increased or decreased according to the patient's conditions). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 1) Volunteer to take part in the study ;
- 2) Age 18~70 (including 70), male or female;
- 3) Gastric cancer or adenocarcinoma of gastroesophageal junction confirmed by histology and/or cytology;
- 4) Has a single initial unresectable factor. For example, peritoneal metastasis (P1),Intraperitoneal free cancer cells positive (CY1), Paraaortic lymph node metastasis, liver metastasis (≤ 3 lesions, and ≤ 5 cm for a single lesion), ovarian metastasis;
- 5) Have not received systematic treatment;
Key exclusion criteria (21 listed)
- 1) Have a history of malignant tumors other than gastric cancer, except for the following two cases:
- 2) Suffering from diseases that affect the absorption, distribution, metabolism or clearance of the study drug (such as severe vomiting, chronic diarrhea, intestinal obstruction, absorption disorder, etc.);
- 3) Have received allogeneic stem cells or solid organ transplantation in the past;
- 4) Patients who have received other anti-tumor systemic therapy in the past (including traditional Chinese medicine with anti-tumor indications), and have been less than 4 weeks from the completion of treatment to the administration of this study, or the adverse events caused by previous treatment have not recovered to ≤ CTCAE level 1 (except hair loss and pigmentation);
- 5) Previous or current congenital or acquired immunodeficiency disease;
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 |
|---|---|---|
| Disitamab VedotinAlso: RC482.5mg/kg，IV，Q3W | Drug | Disitamab Vedotin Combined With Sintilimab and S-1 |
| SintilimabAlso: TYVYT200 mg，IV，Q3W | Drug | Disitamab Vedotin Combined With Sintilimab and S-1 |
| S-1Also: Tegafur，Gimeracil and Oteracil Potassium Capsules40~60mg / m2, bid, d1-14, repeated every 3 weeks. | Drug | Disitamab Vedotin Combined With Sintilimab and S-1 |
| Intraperitoneal chemotherapy with paclitaxelAlso: Paclitaxel (PTX)Paclitaxel (PTX) was used with a dose of 60mg / m2, Q3W. （Only for patients with peritoneal metastases） | Procedure or surgery | Disitamab Vedotin Combined With Sintilimab and S-1 |
Primary outcome
R0 resection rate
Time frame: 1 year
The proportion of patients who underwent R0 surgery among all patients.
4 secondary outcomes
objective response rate (ORR)
Time frame: up to one year
overall survival (OS)
Time frame: From the first dose to death from any cause, up to two years.
Recurrence free survival（RFS）
Time frame: From the first dose to recurrence or death from any cause, up to two years.
safety profile
Time frame: up to 30 days after last treatment administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2022.
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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.
Han Liang, Master principal investigator
ianjin Medical University Cancer Institute and Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Disitamab Vedotin, Sintilimab and S-1 in people with Gastric Cancer, 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 10 inclusion and 21 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 25 Nov 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Han Liang, Master (+8602223340123 ext. 1061, tjlianghan@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
R0 resection rate (time frame: 1 year). 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 25 Nov 2022.