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Trial Title:
Conversion Therapy of Disitamab Vedotin Combined With Sintilimab and S-1 in HER2 Overexpression Gastric Cancer
NCT ID:
NCT05627414
Condition:
Gastric Cancer
Conditions: Official terms:
Stomach Neoplasms
Paclitaxel
Albumin-Bound Paclitaxel
Tegafur
Disitamab vedotin
Conditions: Keywords:
Conversion therapy
Disitamab Vedotin
HER2 overexpression
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Disitamab Vedotin
Description:
2.5mg/kg，IV，Q3W
Arm group label:
Disitamab Vedotin Combined With Sintilimab and S-1
Other name:
RC48
Intervention type:
Drug
Intervention name:
Sintilimab
Description:
200 mg，IV，Q3W
Arm group label:
Disitamab Vedotin Combined With Sintilimab and S-1
Other name:
TYVYT
Intervention type:
Drug
Intervention name:
S-1
Description:
40~60mg / m2, bid, d1-14, repeated every 3 weeks.
Arm group label:
Disitamab Vedotin Combined With Sintilimab and S-1
Other name:
Tegafur，Gimeracil and Oteracil Potassium Capsules
Intervention type:
Procedure
Intervention name:
Intraperitoneal chemotherapy with paclitaxel
Description:
Paclitaxel (PTX) was used with a dose of 60mg / m2, Q3W. （Only for patients with
peritoneal metastases）
Arm group label:
Disitamab Vedotin Combined With Sintilimab and S-1
Other name:
Paclitaxel (PTX)
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 .
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
-
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;
-
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；
Exclusion Criteria:
-
1) Have a history of malignant tumors other than gastric cancer, except for the
following two cases:
1. The patient has received possible curative treatment and there is no evidence
of the disease within 5 years;
2. 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);
-
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:
d) Corticosteroids for intranasal, inhalation, external or local injection (such as
intra-articular injection);
e) The dose of prednisone or other equivalent systemic corticosteroids does not
exceed 10 mg/day;
f) 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Start date:
January 1, 2023
Completion date:
January 1, 2025
Lead sponsor:
Agency:
Tianjin Medical University Cancer Institute and Hospital
Agency class:
Other
Source:
Tianjin Medical University Cancer Institute and Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05627414
