Combination therapies for advanced gastric cancer treatment
A Study of RC48-ADC Combine With Toripalimab and Chemotherapy or RC48-ADC Combine With Toripalimab and Trastuzumab as First-line Treatment in Local Advanced or Metastatic Gastric Cancer With the HER2 Expression
PHASE2; PHASE3 · RemeGen Co., Ltd. · NCT05980481
This study is testing a new combination of treatments for people with advanced gastric cancer to see if it works better than current options.
Quick facts
| Phase | PHASE2; PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | RemeGen Co., Ltd. (industry) |
| Drugs / interventions | chemotherapy, Toripalimab, Trastuzumab |
| Locations | 1 site (Beijing) |
| Trial ID | NCT05980481 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and efficacy of RC48-ADC combined with Toripalimab and either chemotherapy or Trastuzumab as a first-line treatment for patients with HER2-expressing advanced or metastatic gastric cancer. It is a Phase II/III, randomized, multicenter, open-label trial that aims to determine the best combination therapy for this patient population. Participants must have inoperable gastric or gastroesophageal adenocarcinoma and have not received prior systemic treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 with HER2-expressing advanced or metastatic gastric cancer who have not received prior systemic treatment.
Not a fit: Patients with active central nervous system metastases or those with known active infections such as hepatitis B, hepatitis C, or HIV may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for patients with advanced gastric cancer, potentially improving survival rates.
How similar studies have performed: Other studies have shown promising results with similar combination therapies in treating HER2-positive gastric cancer, indicating a potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Voluntary agreement to provide written informed consent. * Age:18-70 years（including 18 and 70）. * Predicted survival ≥ 12 weeks. * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. * Adequate organ function. * All subjects must have inoperable, advanced or metastatic gastric or or gastroesophageal adenocarcinoma. * Subject must be previously untreated with systemic treatment; Subject that received neoadjuvant chemotherapy with recurrence \>6 months from completion of therapy are permitted; * HER2-expressing status determined by laboratory to be IHC 1+, 2+ or 3+. Exclusion Criteria: * Active central nervous system (CNS) metastases. * Known active hepatitis B, active hepatitis C, or human immunodeficiency virus (HIV) infection. * History of other malignancy within the previous 5 years, except for appropriately treated carcinoma in situ of the cervix, thyroid cancer ,etal. * Known hypersensitivity to antibody-drug conjugate(ADC) or PD-(L)1 or any of its components. * Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.
Where this trial is running
Beijing
- Beijing Cancer Hospital — Beijing, China (RECRUITING)
Study contacts
- Study coordinator: Jian min Fang, PhD
- Email: jianminfang@hotmail.com
- Phone: +86-010-58075561
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Gastric Cancer, RC48-ADC, HER2 expression, Gastric cancer