NCT07515625Not yet recruitingPhase 2
Efficacy of Sintilimab Combined With Bevacizumab and XELOX/SOX in Initially Unresectable AFP-positive Gastric/Gastroesophageal Junction Adenocarcinoma
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)
Source: ClinicalTrials.gov · Last updated 7 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 46 (estimated)
- First submitted
- 25 Jan 2026
- Start date
- 1 Apr 2026
- Primary completion date
- 1 Apr 2028
- Lead sponsor
- Fudan University
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT07515625
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 46
- From 1 Apr 2026 to the primary completion date, 1 Apr 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior chemotherapy, radiotherapy, anti-PD-1/PD-L1 therapy, surgery for gastric cancer;
- Significant cardiovascular disease
- --Current treatment with anti-viral therapy or HBV
Other illness
- 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.
Other
- HER2-positive status: IHC 3+, or IHC 2+/FISH+
- Signs of other distant metastases (e.g., peritoneal, lung, bone, supraclavicular lymph, etc.)
- Pregnancy or breastfeeding
Who the study is looking for
- 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;
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.