To hear about similar clinical trials, please enter your email below
Trial Title:
RC48 Combined With Adebrelimab, Apatinib and S-1 as Neoadjuvant Therapy in Locally Advanced Gastric Cancer
NCT ID:
NCT06385873
Condition:
Gastric Cancer/Gastroesophageal Junction Adenocarcinoma
Conditions: Official terms:
Stomach Neoplasms
Apatinib
Tegafur
Disitamab vedotin
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:
RC48
Description:
RC48: 2.5 mg/kg, intravenous infusion, on day 1, every 3 weeks (Q3W);
Arm group label:
Experimental
Other name:
Disitamab Vedotin
Intervention type:
Drug
Intervention name:
Adebrelimab
Description:
Adebrelimab：1200 mg, intravenous infusion, on day 1, every 3 weeks (Q3W);
Arm group label:
Experimental
Intervention type:
Drug
Intervention name:
Apatinib
Description:
Apatinib: 250mg, oral administration, once daily (qd), every 3 weeks (Q3W);
Arm group label:
Experimental
Intervention type:
Drug
Intervention name:
S-1
Description:
S-1：For patients with a body surface area (BSA) ≤1.5m², use 50mg each time; for patients
with BSA >1.5m², use 60mg each time, oral administration, twice daily (bid), on days
1-14, every 3 weeks (Q3W);
Arm group label:
Experimental
Other name:
S-1tegafur, gimeracil and oteracil potassium
Summary:
This study is a prospective, open-label, phase II clinical trial that aims to enroll
patients with locally advanced gastric adenocarcinoma who have not received any prior
treatment and are candidates for surgery. The study drugs include RC48, Adebrelimab,
Apatinib and S-1. The purpose is to evaluate the effectiveness and safety of the combined
coordinated treatment of multi-mechanism drugs for perioperative treatment of locally
advanced gastric cancer with HER2 overexpression.
Detailed description:
The study plans to enroll 32 subjects. After signing the informed consent form and
meeting the inclusion and exclusion criteria, patients will receive standard-dose
treatment of the RC48, Adebrelimab, Apatinib and S-1 regimen for 3-4 cycles (every 3
weeks) before surgery. Apatinib will only be used for 14 days in the last cycle. Imaging
studies will be conducted 3-4 weeks after the last dose to assess the efficacy of
neoadjuvant therapy and the possibility of radical D2 gastrectomy. The treatment plan
after curative surgery for gastric cancer will be determined by the investigators and the
patients based on the pathological findings. Patients who benefit clinically after
surgery may receive adjuvant therapy with RC48, Adebrelimab, Apatinib and S-1 for 4
cycles (the first treatment is expected to start around 4 weeks after surgery) or follow
the standard postoperative adjuvant regimen recommended by the guidelines.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
-
1. Participants voluntarily join this study, are able to complete the signing of
the informed consent form, and have good compliance;
-
2. Age between 18 to 75 years old (at the time of signing the informed consent
form), with no gender restrictions;
-
3. Gastrointestinal cancer or gastroesophageal junction adenocarcinoma confirmed
by histology and/or cytology, diagnosed as locally advanced according to the
8th edition of the AJCC standards, with a cTNM diagnosis of T3-4aN+M0 and
T4aNanyM0 based on ultrasound endoscopy or enhanced CT/MRI scan (and diagnostic
laparoscopy if necessary), and agree to receive curative surgical treatment,
with the investigator assessing the potential for tumor resectability;
-
4. Have not previously received systemic treatment for the current disease,
including anti-tumor chemotherapy/immunotherapy, etc.;
-
5. HER2 overexpression confirmed by IHC results from endoscopic biopsy tissue
(defined as: IHC 2+, 3+);
-
6. ECOG score of 0-1;
-
7. Estimated life expectancy of ≥6 months;
-
8. Good major organ function:
Exclusion Criteria:
-
1. Concurrent malignant disease other than gastric cancer (excluding early-stage
tumors that have been radically treated);
-
2. Tumor lesions with a tendency to bleed (such as active ulcerative tumor lesions
with positive fecal occult blood test, history of hematemesis or melena within
2 months before signing the informed consent form, or assessed by the
investigator as being at risk of significant gastrointestinal hemorrhage, etc.)
or having received blood transfusion treatment within 4 weeks before the study
medication; 3. Inability to take oral medication;
-
4. Currently participating in another interventional clinical study treatment, or
having received other investigational drugs or used investigational medical
devices within 4 weeks before the first administration of the study medication;
-
5. Has had systemic treatment required within 2 years before the first
administration of the study medication;
-
6. Known allogeneic organ transplantation (except for corneal transplantation);
-
7. Known allergy to any medication used in this study;
-
8. Peripheral neuropathy of grade ≥2;
-
9. Known history of human immunodeficiency virus (HIV) infection (i.e., positive
for HIV 1/2 antibodies);
-
10. Active hepatitis B or C infection;
-
11. Received live vaccines within 30 days before the first administration (Day 1 of
Cycle 1);
-
12. Pregnant or breastfeeding women;
-
13. Presence of any severe or uncontrollable systemic disease.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
May 1, 2024
Completion date:
May 1, 2028
Lead sponsor:
Agency:
The First Affiliated Hospital with Nanjing Medical University
Agency class:
Other
Source:
The First Affiliated Hospital with Nanjing Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06385873
