Conversion Therapy With Retlirafusp Alfa Plus Chemotherapy in Gastric or Gastroesophageal Junction Adenocarcinoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorTang-Du Hospital
About this trial
This is a prospective, single-arm, exploratory clinical study designed to evaluate the efficacy and safety of retlirafusp alfa plus CAPOX as conversion therapy in patients with potentially resectable gastric or gastroesophageal junction adenocarcinoma. Eligible participants will receive preoperative retlirafusp alfa in combination with capecitabine and oxaliplatin. Patients who achieve complete response or partial response and are considered suitable for R0 resection after multidisciplinary team assessment will undergo radical surgery. The primary outcome is R0 resection rate.
Eligibility criteria
Qualifiers
Histologically confirmed gastric or gastroesophageal junction adenocarcinoma by gastroscopic biopsy.
Potentially resectable gastric or gastroesophageal junction adenocarcinoma as judged by the investigator, including but not limited to: T4b disease or fixed/fused lymph nodes; single liver metastasis, limited para-aortic lymph node metastasis (No.16a2/b1), or CY1P0 disease; more than one liver metastasis or a liver metastasis larger than 5 cm adjacent to the hepatic vein or portal vein, extensive para-aortic lymph node metastasis (No.16a1/b2), or selected distant metastases such as Virchow lymph node or lung metastasis.
HER2-low, HER2-intermediate, or HER2-negative disease, and PD-L1 CPS ≥1.
Age 18 to 75 years.
Disqualifiers
History of malignancy within 5 years or current presence of another malignancy.
Prior systemic therapy for advanced or metastatic gastric or gastroesophageal junction adenocarcinoma.
Macroscopically visible peritoneal metastasis or other unresectable distant metastasis.
Active bleeding from the tumor as shown by endoscopy.
Trial design
Treatments tested in this trial
- Retlirafusp Alfa
- Oxaliplatin
- Capecitabine
- Radical Surgery
Treatment groups
21 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov