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NOT YET RECRUITING
NCT07233850
PHASE2

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

Sponsor: Shenyang Sunshine Pharmaceutical Co., LTD.

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2025-11

Completion Date

2027-12

Last Updated

2025-11-18

Healthy Volunteers

No

Interventions

DRUG

SSGJ-706+XELOX

SSGJ-706 (administered on Day 1 of each cycle, Q3W)+Oxaliplatin (130 mg/m2 intravenous infusion for 2-6 hours on Day 1, Q3W,up to 6 cycles)+ Capecitabine(1000 mg/m2, p.o., Bid, D1-D14, Q3W,up to 6 cycles) . Afterward, SSGJ-706 (administered on Day 1 of each cycle, Q3W) and Capecitabine (1000 mg/m2, p.o., Bid, D1-D14, Q3W) will be used for maintenance treatment.

DRUG

SSGJ-706+Bevacizumab+XELOX

SSGJ-706 (administered on Day 1 of each cycle, Q3W)+Bevacizumab (7.5 mg/kg intravenous infusion on Day 1 of each cycle, Q3W)+Oxaliplatin (130 mg/m2 intravenous infusion for 2-6 hours on Day 1, Q3W,up to 8 cycles)+ Capecitabine(1000 mg/m2, p.o., Bid, D1-D14, Q3W,up to 8 cycles) . Afterward, SSGJ-706 (administered on Day 1 of each cycle, Q3W), Bevacizumab (7.5 mg/kg intravenous infusion on Day 1 of each cycle, Q3W) and Capecitabine (1000 mg/m2, p.o., Bid, D1-D14, Q3W) will be used for maintenance treatment.

DRUG

SSGJ-706+AG

SSGJ-706 (administered on Day 1 of each cycle, Q2W)+Albumin-bound Paclitaxel (125 mg/m2 intravenous infusion on Days 1, 8, 15 of each 28-day cycle)+ Gemcitabine(1000 mg/m2 intravenous infusion on Days 1, 8, 15 of each 28-day cycle) .

DRUG

SSGJ-706+TP

SSGJ-706 (administered on Day 1 of each cycle, Q3W)+Paclitaxel (175 mg/m2 intravenous infusion on Day 1, Q3W)+ Cisplatin(60-80 mg/m2 intravenous infusion on Day 1, Q3W) .

Locations (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China