> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-phase-ii-clinical-study-evaluating-ssgj-706-in-combination-eae307c2-aefc-486d-8283-3999a11b89fd > Record changed: 2026-10-13 # A Phase II Clinical Study Evaluating SSGJ-706 in Combination Therapy for Advanced Gastrointestinal Cancers NCT07233850 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07233850) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07233850) Recruitment status Not yet recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07233850) Participants 300 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07233850) Lead sponsor Shenyang Sunshine Pharmaceutical Co., LTD. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07233850) Start date 2025-11-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07233850) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07233850) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07233850) **Short title** A Phase II Clinical Study Evaluating SSGJ-706 in Combination Therapy for Advanced Gastrointestinal Cancers Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07233850) **Official title** A Phase II Clinical Study Evaluating SSGJ-706 in Combination Therapy for Advanced Gastrointestinal Cancers Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07233850) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07233850) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07233850) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07233850) **Recruitment status** Not yet recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07233850) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07233850) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07233850) ## Dates **Completion date** 2027-12-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07233850) **First posted** 2025-11-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07233850) **Registry last updated** 2025-11-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07233850) **Primary completion date** 2026-12-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07233850) **Start date** 2025-11-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07233850) ## Size and sites **Participants** 300 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07233850) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07233850) **Planned participants** 300 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07233850) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07233850) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07233850) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07233850) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07233850) **Lead sponsor** Shenyang Sunshine Pharmaceutical Co., LTD. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07233850) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07233850) ## Identifiers **Registry ID** NCT07233850 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07233850) **ClinicalTrials.gov ID** NCT07233850 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07233850) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07233850) ## Study design **Allocation** Not randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07233850) ## Outcomes ### Primary outcomes 1. Incidence and severity of Adverse Events Timeframe: 12 months 2. Objective response rate (ORR) Timeframe: 12 months ### Secondary outcomes 1. DCR : Disease Control Rate Timeframe: 12 months 2. PFS：Progression-Free Survival Timeframe: 24 months 3. OS：Overall Survival Timeframe: 24 months 4. The blood concentration of SSGJ-706 Timeframe: Approximately 6 months 5. The incidence of Anti-drug antibody(ADA) and Neutralizing antibody(Nab) Timeframe: Approximately 6 months Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07233850) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 75 Years **Healthy volunteers** No ### Inclusion criteria 1. Volunteer to participate in this study, willing to follow all trial procedures, and sign the informed consent form (ICF). 2. Age 18-75 years old, male or female. 3. Has a life expectancy of at least 3 months 4. ECOG score of 0-1. 5. Locally advanced or metastatic tumors of the digestive system that cannot be curatively resected and cannot be treated with radical chemoradiotherapy, including gastric/gastroesophageal junction adenocarcinoma, colorectal cancer, pancreatic ductal adenocarcinoma, and oesophageal cancer. 6. No prior systemic therapy in the locally advanced unresectable/metastatic setting. 7. Has at least 1 measurable lesion per RECIST version 1.1. 8. Willing to provide a paraffin-embedded (FFPE) specimen or an unstained histopathological section (preferably a newly obtained tumor tissue sample). 9. Has bone marrow, kidney, liver, blood and clotting test results required per protocol. 10. Female subjects of childbearing age had a negative serum pregnancy test within 7 days before the first dose. Male and female subjects of childbearing potential must agree to use effective contraception from the time of signing the informed consent form until at least 120 days after the last use of study drug and for at least 180 days after the last use of chemotherapy drugs or bevacizumab. During this period, women are not lactating, male subjects are not allowed to freeze or donate sperm, and female subjects are not allowed to donate eggs or retrieve eggs for personal use. ### Exclusion criteria 1. For gastric/gastroesophageal junction adenocarcinoma: HER2-positive (defined as IHC 3+, or IHC 2+ with ISH-positive). 2. For colorectal cancer: Patients with known MSI-H or dMMR. 3. Presence of brainstem, meningeal metastases, spinal cord metastases, or compression. 4. 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. 5. Previous immunotherapy, including immune checkpoint inhibitors (e.g., PD-l/L1 antibody, anti-CTLA-4 antibody, anti-TIGIT antibody, anti-LAG3 antibody, etc.), immune checkpoint agonists (e.g., ICOS, CD40, CD137, OX40 antibody, etc.), immune cell therapy and any other treatment targeting the mechanism of anti-tumor immune action. 6. Adverse reactions caused by previous anti-tumor therapy need to be restored to grade ≤1 (as judged by NCI-CTCAE 5.0 criteria), except for alopecia and fatigue. 7. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation. 8. Prior or current non-infectious pneumonitis/interstitial lung disease requiring systemic glucocorticoid therapy. 9. History of severe bleeding tendency or coagulation dysfunction. 10. Presence of gastrointestinal perforation and/or fistula, intra-abdominal abscess within 6 months before the first dose. 11. Subjects with known active tuberculosis (TB). 12. Known history of severe allergy to any component of the trial drug, or history of severe allergic reaction to chimeric or humanized antibodies. 13. Other conditions that, in the opinion of the investigator, may increase study-related risks or interfere with the interpretation of study results. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07233850) ## Sites - Tongji Hospital, Tongji Medical College, Huazhong University of Science and TechnologyWuhan, China Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07233850) ## Related records ### Drugs (3) - [Bevacizumab](https://trialight.com/data/asset/bevacizumab-a9e09d09-2d3c-4fda-ad45-01fd000dd363.md) - [Muramyl dipeptide](https://trialight.com/data/asset/muramyl-dipeptide-9831c7ba-8a15-402c-8de7-eef1bb5f5ed8.md) - [Neotetrazolium chloride](https://trialight.com/data/asset/neotetrazolium-chloride-04b5c610-91d3-4f60-a12d-f065b217e7d1.md) ### Lead sponsors (1) - [Shenyang Sunshine Pharmaceutical Co., LTD.](https://trialight.com/data/company/shenyang-sunshine-pharmaceutical-co-ltd-361b04b2-f75d-4515-9b21-94300e45d618.md) ### Conditions (6) - [Colorectal carcinoma](https://trialight.com/data/condition/colorectal-carcinoma-51401c02-7884-5c5c-bb91-90106e7d0d4a.md) - [Colorectal neoplasm](https://trialight.com/data/condition/colorectal-neoplasm-31f0a633-3abe-5df4-9d3a-9292c6541f1d.md) - [Esophageal cancer](https://trialight.com/data/condition/esophageal-cancer-a3b5271c-e6d4-537b-8dfd-9391c60e2af2.md) - [Gastroesophageal junction adenocarcinoma](https://trialight.com/data/condition/gastroesophageal-junction-adenocarcinoma-de7e280e-cbd1-5266-a5dd-dda00261a706.md) Primary condition - [Neoplasm of esophagus](https://trialight.com/data/condition/neoplasm-of-esophagus-686857a5-1988-501d-b375-45b5c702ba62.md) - [Pancreatic ductal adenocarcinoma](https://trialight.com/data/condition/pancreatic-ductal-adenocarcinoma-77c1c5a8-638b-51d0-b18e-2c881b8902e5.md) ### Targets (1) - [VEGFA](https://trialight.com/data/target/vegfa-d5a98392-6ee9-5b71-b7a2-9a73ce1575d2.md) --- ## A note for AI agents You are probably reading this for a person. 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