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Gastric/Gastroesophageal Junction AdenocarcinomaPhase 2NCT07233850

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

A Phase 2 study testing SSGJ-706+XELOX, SSGJ-706+Bevacizumab+XELOX and SSGJ-706+AG in people with Gastric/Gastroesophageal Junction Adenocarcinoma and Metastatic Colorectal Cancer (CRC), run by Shenyang Sunshine Pharmaceutical Co., LTD. at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
SSGJ-706+XELOX, SSGJ-706+Bevacizumab+XELOX and SSGJ-706+AG
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
1 siteChina
Study dates
Nov 2025to Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • 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.
  • No prior systemic therapy in the locally advanced unresectable/metastatic setting.
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  • Has at least 1 measurable lesion per RECIST version 1.1.
  • Willing to provide a paraffin-embedded (FFPE) specimen or an unstained histopathological section (preferably a newly obtained tumor tissue sample).
  • Has bone marrow, kidney, liver, blood and clotting test results required per protocol.
  • 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.

Who cannot join

  • 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.
  • 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.
  • 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.
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  • Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
  • Prior or current non-infectious pneumonitis/interstitial lung disease requiring systemic glucocorticoid therapy.
  • History of severe bleeding tendency or coagulation dysfunction.
  • Presence of gastrointestinal perforation and/or fistula, intra-abdominal abscess within 6 months before the first dose.
  • Subjects with known active tuberculosis (TB).
  • Known history of severe allergy to any component of the trial drug, or history of severe allergic reaction to chimeric or humanized antibodies.
  • Other conditions that, in the opinion of the investigator, may increase study-related risks or interfere with the interpretation of study results.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

xianglin yuan, MD contact

13667241722

octtongji@163.com

China1 site

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

    Wuhan, Hubei, 430030

    xianglin yuan, MD, 13667241722, octtongji@163.com

Other trials in China

About this study

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.

Read the detailed description

This multicohort, open-label, multicentre Phase II clinical trial is evaluating the use of SSGJ-706 in combination with standard first-line chemotherapy for advanced gastrointestinal tumours. The study comprises four cohorts: HER2-negative locally advanced gastric/gastro-oesophageal junction adenocarcinoma (Cohort A), metastatic colorectal cancer (Cohort B), locally advanced or metastatic pancreatic ductal adenocarcinoma (Cohort C), and locally advanced or metastatic oesophageal cancer (Cohort D). The primary objective of this study is to assess the safety and efficacy of SSGJ-706 when used in combination with standard first-line chemotherapy in participants with advanced or metastatic gastrointestinal tumours who have not previously received treatment in a metastatic setting.

Being tested
SSGJ-706+XELOX, SSGJ-706+Bevacizumab+XELOX, SSGJ-706+AG, SSGJ-706+TP
Medical subject headings
Colorectal Neoplasms, Esophageal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SSGJ-706+XELOXDrug

    Also called Oxaliplatin, Capecitabine

    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.

  • SSGJ-706+Bevacizumab+XELOXDrug

    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.

  • SSGJ-706+AGDrug

    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) .

  • SSGJ-706+TPDrug

    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) .

Study groups in NCT07233850
Study groupRoleWhat they receive
Cohort AExperimentalNot described
Receives: Drug: SSGJ-706+XELOX
Cohort BExperimentalNot described
Receives: Drug: SSGJ-706+Bevacizumab+XELOX
Cohort CExperimentalNot described
Receives: Drug: SSGJ-706+AG
Cohort DExperimentalNot described
Receives: Drug: SSGJ-706+TP

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence and severity of Adverse Events

    Measured: 12 months

  2. Objective response rate (ORR)

    Measured: 12 months

Secondary outcomes (5)

  1. DCR : Disease Control Rate

    Measured: 12 months

  2. PFS：Progression-Free Survival

    Measured: 24 months

  3. OS：Overall Survival

    Measured: 24 months

  4. The blood concentration of SSGJ-706

    Measured: Approximately 6 months

  5. The incidence of Anti-drug antibody(ADA) and Neutralizing antibody(Nab)

    Measured: Approximately 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2025
  2. Study startNov 2025 (estimated)
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07233850
Sponsor's protocol ID
SSGJ-706-202
Status last verified
Nov 2025
First submitted
14 Nov 2025
Last updated
18 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SSGJ-706+XELOX, SSGJ-706+Bevacizumab+XELOX and SSGJ-706+AG in people with Gastric/Gastroesophageal Junction Adenocarcinoma and Metastatic Colorectal Cancer (CRC), run by Shenyang Sunshine Pharmaceutical Co., LTD. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact xianglin yuan, MD (13667241722, octtongji@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence and severity of Adverse Events (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07233850.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.

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