Gastric Cancer Clinical Trial
Official title:
A Prospective, Single-arm, Exploratory Clinical Research on the Efficacy and Safety of Tripletrumab Combined With Oxaliplatin and Teggio (SOX) in First-line Treatment of Unresectable Locally Advanced or Metastatic Gastric and Gastroesophageal Junction Adenocarcinoma
The aim population is histopathologically confirmed locally unresectable advanced recurrent
or metastatic adenocarcinoma of the gastric and gastroesophageal junction. Purpose of
research to evaluate the efficacy and safety of tripletrumab combined with oxaliplatin and
teggio (SOX) in first-line treatment of unreactable locally advanced, recurrent or metastatic
gastric and gastroesophageal junction adenocarcinoma.
Every 21 days is a cycle, and treatment is scheduled for 6 cycles. Chemotherapy drugs until
disease progression, toxicity intolerance, the start of new anti - tumor treatment,
withdrawal, loss of access or death, etc., already reached first, shall be the basis for
termination.
Treatment was effective for more than 6 treatment cycles and toxicity was, the subjects were
judged by the researchers when to terminate the treatment and adjust the follow-up treatment
plan.
For disease progression, toxicity intolerance, and initiation of new antitumor therapies.
For subjects who donot reach terminal events such as treatment, withdrawal, loss of follow-up
or death, at the end of chemotherapy , the follow-up maintenance regimen was adjusted
according to the researchers' evaluation.
The screening period of the study was 14 days. The screening test was completed and the
evaluation was completed.
Subjects with standard discharge entered the treatment period, and the frequency of
administration was determined according to the protocol.
Conduct treatment and complete relevant tests and assessments before each administration.
Tumor imaging was assessed every 6 weeks (±7 days) and all subjects were treated.
At the end of the visit, safety and imaging evaluations should be completed. Complete
follow-up was conducted for a total of 90 days. Continue to receive tumor evaluation and
imaging at a frequency of 2-3 months. Evaluation until disease progression, new antitumor
therapy, withdrawal, Lost or dead, etc.
n/a
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