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New treatment option for Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma
Official title SHR-1701 Combined With Chemotherapy for Gastric or Gastroesophageal Junction Adenocarcinoma With Peritoneal Metastasis
ClinicalTrials.gov ID: NCT07384234
What this study is testing
What is SHR-1701?
SHR-1701 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for gastric adenocarcinoma and gastroesophageal junction adenocarcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is a prospective, randomized, two-cohort trial designed to evaluate the efficacy and safety of two regimens in the treatment of gastric or gastroesophageal junction adenocarcinoma with peritoneal metastasis: SHR-1701 combined with intravenous and intraperitoneal paclitaxel plus S-1, or SHR-1701 combined with CAPOX.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18 years old.
- Pathologically confirmed gastric or gastroesophageal junction adenocarcinoma (Siewert typeⅡ and type Ⅲ gastroesophageal junction adenocarcinoma are...
- Definitively diagnosed with peritoneal metastasis by exploratory laparoscopy and/peritoneal lavage cytology (CY0P1/CY1P0/CY1P1 are eligible, ovarian...
- No prior anti-tumor treatment history (including radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.).
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
You likely can't join if
- Known HER2-positive.
- Previous history of gastric cancer surgery.
- Contraindications to surgical treatment or chemotherapy, or poor physical status and organ function precluding major abdominal surgery.
- Presence of distant metastases other than peritoneal metastases (e.g., liver, lung, ovarian, para-aortic lymph node, brain metastases, etc.).
- Active autoimmune disease within 4 weeks prior to enrollment or a history of autoimmune disease.
- Significant cardiovascular disease within 6 months prior to enrollment, including unstable angina or myocardial infarction.
See the full eligibility criteria
- Age ≥ 18 years old.
- Pathologically confirmed gastric or gastroesophageal junction adenocarcinoma (Siewert typeⅡ and type Ⅲ gastroesophageal junction adenocarcinoma are eligible for inclusion).
- Definitively diagnosed with peritoneal metastasis by exploratory laparoscopy and/peritoneal lavage cytology (CY0P1/CY1P0/CY1P1 are eligible, ovarian metastasis is permitted), and without gastric outlet obstruction or...
- No prior anti-tumor treatment history (including radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.).
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
- Normal function of major organs.
- Known HER2-positive.
- Previous history of gastric cancer surgery.
- Contraindications to surgical treatment or chemotherapy, or poor physical status and organ function precluding major abdominal surgery.
- Presence of distant metastases other than peritoneal metastases (e.g., liver, lung, ovarian, para-aortic lymph node, brain metastases, etc.).
- Active autoimmune disease within 4 weeks prior to enrollment or a history of autoimmune disease.
- Significant cardiovascular disease within 6 months prior to enrollment, including unstable angina or myocardial infarction.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China; Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.