Gastric Cancer (GC)Phase 2NCT07515625
Efficacy of Sintilimab Combined With Bevacizumab and XELOX/SOX in Initially Unresectable AFP-positive Gastric/Gastroesophageal Junction Adenocarcinoma
A Phase 2 study testing Sintilimab, Bevacizumab and Oxaliplatin in people with Gastric Cancer (GC) and AFP Gastric or Gastroesophageal Junction Adenocarcinoma, run by Fudan University.
Trial summary
Alpha-fetoprotein-producing gastric cancer (AFP-positive gastric cancer, AFP-GC), a rare and highly aggressive subtype of gastric cancer, accounts for 1.3% to 15% of all gastric cancer cases. Its clinical features are significantly different from those of common gastric cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer (GC), AFP Gastric or Gastroesophageal Junction Adenocarcinoma
- What is being tested?
- Sintilimab, Bevacizumab and Oxaliplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 1 Apr 2029
- 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
- Signed informed consent;
- Patients age 18-75 years;
- Histologically CT/MRI confirmed cT3-4N+M0/1 gastric or GEJ adenocarcinoma; (M1 only includes type I liver metastasis of gastric cancer, according to the "Chinese Expert Consensus on Liver Metastasis of Gastric Cancer");
- Serum AFP levels > 2× upper limit of normal or AFP-positive by IHC staining;
- Adequate organ function
- ECOG 0-1, no surgery contraindications;
- Expected survival ≥3 months;
Who cannot join
- HER2-positive status: IHC 3+, or IHC 2+/FISH+
- Prior chemotherapy, radiotherapy, anti-PD-1/PD-L1 therapy, surgery for gastric cancer;
- Signs of other distant metastases (e.g., peritoneal, lung, bone, supraclavicular lymph, etc.)
- Significant cardiovascular disease
- --Current treatment with anti-viral therapy or HBV
- Pregnancy or breastfeeding
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- History of malignancy within 5 years prior to screening
- Present or history of any autoimmune disease or immune deficiency;
- There are active gastric and duodenal ulcers, ulcerative colitis and other gastrointestinal diseases, or active bleeding in unresectable tumors.
About this study
Official title: Conversion Therapy of Sintilimab Combined With Bevacizumab and XELOX/SOX for Initially Unresectable AFP-positive Gastric/Esophagogastric Junction Adenocarcinoma : A Multi-center, Single-arm, Phase II Trial (SOLIDS-02)
Alpha-fetoprotein-producing gastric cancer (AFP-positive gastric cancer, AFP-GC), a rare and highly aggressive subtype of gastric cancer, accounts for 1.3% to 15% of all gastric cancer cases. Its clinical features are significantly different from those of common gastric cancer. Not only does it show abnormally elevated serum AFP levels, but it also has a stronger angiogenic ability, a higher rate of distant metastasis, and a poorer prognosis even after a upfront R0 surgery, making it a challenging problem in the field of gastric cancer treatment. Notably, patients with AFP-positive gastric cancer have a relatively low sensitivity to the traditional standard regimens. There is an urgent need to explore targeted treatment strategies to break through the efficacy bottleneck.
Combination of sintilimab, bevacizumab and XELOX/SOX for initially unresectable AFP-positive gastric/esophagogastric junction adenocarcinoma could be a novel therapeutic strategy to increase response rate and therapeutic efficacy. This study is a multi-center, single-arm phase 2 clinical trial to evaluate efficacy, tolerability and safety of perioperative sintilimab in combination with bevacizumab and XELOX/SOX in initially unresectable AFP-positive gastric/esophagogastric junction adenocarcinoma.
- Being tested
- Sintilimab, Bevacizumab, Oxaliplatin, Capecitabine, S-1
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SintilimabDrug
Sintilimab, recombinant humanized anti-PD-1 monoclonal antibody for injection; 200mg iv drip，d1, q3w
BevacizumabDrug
7.5mg/kg，iv drip，d1, q3w
OxaliplatinDrug
130mg/m2，iv drip for 2h，d1, q3w
CapecitabineDrug
1000mg/m2 twice daily, d1-14, q3w
S-1Drug
40~60mg Bid，d1~14, q3w
| Study group | Role | What they receive |
|---|---|---|
| Sintilimab, bevacizumab and chemotherapy (XELOX/SOX) | Experimental | Sintilimab: 200mg, ivdrip, d1, q3w; Bevacizumab:7.5mg/kg，iv drip，d1, q3w; XELOX:Oxaliplatin+ Capecitabine Capecitabine: 1000mg/m2 twice daily, d1-14, q3w Oxaliplatin: 130mg/m2, ivdrip,d1, q3w; SOX: Oxaliplatin+S-1 S-1:40~60mg Bid, d1~14, q3w Oxaliplatin: 130mg/m2, ivdrip,d1, q3w; Receives: Drug: Sintilimab; Drug: Bevacizumab; Drug: Oxaliplatin; Drug: Capecitabine; Drug: S-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate(ORR)
Objective response rate(ORR):CR+PR
Measured: From first dose to end of study treatment or last tumor assessment prior to conversion surgery or disease progression.Up to 24 weeks.
Secondary outcomes (4)
R0 resection rate
Measured: From the initiation date of first cycle (each cycle is 21 days) to the date of operation.Up to 24 weeks.
Major pathological response rate
Measured: From the initiation date of first cycle (each cycle is 21 days) to the date of operation.Up to 24 weeks.
One year progression-free survival (PFS)
Measured: From the initiation date of first cycle (each cycle is 21 days) to the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year.
One year overall survival(OS)
Measured: The Kaplan-Meier survival from the initiation date of first cycle until death from any cause or the last follow-up date,assessed up to 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start1 Apr 2026 (estimated)
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Cancer (GC)Studies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fenglin Liu, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07515625
- Sponsor's protocol ID
- SOLIDS study-02
- Other IDs
- Shanghai Cancer Center
- Status last verified
- Mar 2026
- First submitted
- 25 Jan 2026
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conversion Therapy of Sintilimab Combined With Bevacizumab and XELOX/SOX for Initially Unresectable AFP-positive Gastric/Esophagogastric Junction Adenocarcinoma : A Multi-center, Single-arm, Phase II Trial (SOLIDS-02)
- ClinicalTrials.gov ID
- NCT07515625
- Acronym / sponsor ID
- SOLIDS study-02
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 Apr 2029 (estimated)
- First posted
- 7 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Alpha-fetoprotein-producing gastric cancer (AFP-positive gastric cancer, AFP-GC), a rare and highly aggressive subtype of gastric cancer, accounts for 1.3% to 15% of all gastric cancer cases. Its clinical features are significantly different from those of common gastric cancer. Not only does it show abnormally elevated serum AFP levels, but it also has a stronger angiogenic ability, a higher rate of distant metastasis, and a poorer prognosis even after a upfront R0 surgery, making it a challenging problem in the field of gastric cancer treatment. Notably, patients with AFP-positive gastric cancer have a relatively low sensitivity to the traditional standard regimens. There is an urgent need to explore targeted treatment strategies to break through the efficacy bottleneck.
Combination of sintilimab, bevacizumab and XELOX/SOX for initially unresectable AFP-positive gastric/esophagogastric junction adenocarcinoma could be a novel therapeutic strategy to increase response rate and therapeutic efficacy. This study is a multi-center, single-arm phase 2 clinical trial to evaluate efficacy, tolerability and safety of perioperative sintilimab in combination with bevacizumab and XELOX/SOX in initially unresectable AFP-positive gastric/esophagogastric junction adenocarcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sintilimab, bevacizumab and chemotherapy (XELOX/SOX) | Experimental | Drug: Sintilimab, Drug: Bevacizumab, Drug: Oxaliplatin, Drug: Capecitabine, Drug: S-1Sintilimab: 200mg, ivdrip, d1, q3w; Bevacizumab:7.5mg/kg，iv drip，d1, q3w; XELOX:Oxaliplatin+ Capecitabine Capecitabine: 1000mg/m2 twice daily, d1-14, q3w Oxaliplatin: 130mg/m2, ivdrip,d1, q3w; SOX: Oxaliplatin+S-1 S-1:40~60mg Bid, d1~14, q3w Oxaliplatin: 130mg/m2, ivdrip,d1, q3w; |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Signed informed consent;
- Patients age 18-75 years;
- Histologically CT/MRI confirmed cT3-4N+M0/1 gastric or GEJ adenocarcinoma; (M1 only includes type I liver metastasis of gastric cancer, according to the "Chinese Expert Consensus on Liver Metastasis of Gastric Cancer");
- Serum AFP levels > 2× upper limit of normal or AFP-positive by IHC staining;
- Adequate organ function
Key exclusion criteria (9 listed)
- HER2-positive status: IHC 3+, or IHC 2+/FISH+
- Prior chemotherapy, radiotherapy, anti-PD-1/PD-L1 therapy, surgery for gastric cancer;
- Signs of other distant metastases (e.g., peritoneal, lung, bone, supraclavicular lymph, etc.)
- Significant cardiovascular disease
- --Current treatment with anti-viral therapy or HBV
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SintilimabSintilimab, recombinant humanized anti-PD-1 monoclonal antibody for injection; 200mg iv drip，d1, q3w | Drug | Sintilimab, bevacizumab and chemotherapy (XELOX/SOX) |
| Bevacizumab7.5mg/kg，iv drip，d1, q3w | Drug | Sintilimab, bevacizumab and chemotherapy (XELOX/SOX) |
| Oxaliplatin130mg/m2，iv drip for 2h，d1, q3w | Drug | Sintilimab, bevacizumab and chemotherapy (XELOX/SOX) |
| Capecitabine1000mg/m2 twice daily, d1-14, q3w | Drug | Sintilimab, bevacizumab and chemotherapy (XELOX/SOX) |
| S-140~60mg Bid，d1~14, q3w | Drug | Sintilimab, bevacizumab and chemotherapy (XELOX/SOX) |
Primary outcome
Objective response rate(ORR)
Time frame: From first dose to end of study treatment or last tumor assessment prior to conversion surgery or disease progression.Up to 24 weeks.
Objective response rate(ORR):CR+PR
4 secondary outcomes
R0 resection rate
Time frame: From the initiation date of first cycle (each cycle is 21 days) to the date of operation.Up to 24 weeks.
Major pathological response rate
Time frame: From the initiation date of first cycle (each cycle is 21 days) to the date of operation.Up to 24 weeks.
One year progression-free survival (PFS)
Time frame: From the initiation date of first cycle (each cycle is 21 days) to the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year.
One year overall survival(OS)
Time frame: The Kaplan-Meier survival from the initiation date of first cycle until death from any cause or the last follow-up date,assessed up to 1 year.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sintilimab, Bevacizumab and Oxaliplatin in people with Gastric Cancer (GC) and AFP Gastric or Gastroesophageal Junction Adenocarcinoma, run by Fudan University.
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 7 inclusion and 9 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 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate(ORR) (time frame: From first dose to end of study treatment or last tumor assessment prior to conversion surgery or disease progression.Up to 24 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Apr 2026.