A Phase II Clinical Study Evaluating SSGJ-706 in Combination Therapy for Advanced Gastrointestinal Cancers

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShenyang Sunshine Pharmaceutical Co., LTD.

About this trial

This study is a multicenter, open-label, phase II clinical trial evaluating the combination of SSGJ-706 with standard therapy for advanced gastrointestinal tumors. Its objective is to assess the safety, tolerability, and antitumor activity of SSGJ-706 in combination with standard treatment.

Eligibility criteria

Qualifiers

Volunteer to participate in this study, willing to follow all trial procedures, and sign the informed consent form (ICF).

Age 18-75 years old, male or female.

Has a life expectancy of at least 3 months

ECOG score of 0-1.

Disqualifiers

For gastric/gastroesophageal junction adenocarcinoma: HER2-positive (defined as IHC 3+, or IHC 2+ with ISH-positive).

For colorectal cancer: Patients with known MSI-H or dMMR.

Presence of brainstem, meningeal metastases, spinal cord metastases, or compression.

Presence of active central nervous system (CNS) metastases; Subjects with previously treated brain metastases (such as surgery, radiotherapy) are allowed to enroll if they are clinically stable for at least four weeks after treatment (until the first dose of study drug) and corticosteroids are discontinued 3 days before the first dose of study drug; Subjects with untreated, asymptomatic brain metastases can be enrolled.

Trial design

Treatments tested in this trial

  • SSGJ-706+XELOX
  • SSGJ-706+Bevacizumab+XELOX
  • SSGJ-706+AG
  • SSGJ-706+TP

Treatment groups

300 Participants
are divided into 4 treatment groups