Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| Shanghai Cancer Center | Other Identifier | Fudan University |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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; |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sintilimab | Drug | Sintilimab, recombinant humanized anti-PD-1 monoclonal antibody for injection; 200mg iv drip，d1, q3w |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate(ORR) | Objective response rate(ORR):CR+PR | From first dose to end of study treatment or last tumor assessment prior to conversion surgery or disease progression.Up to 24 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| R0 resection rate | 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 | From the initiation date of first cycle (each cycle is 21 days) to the date of operation.Up to 24 weeks. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Bevacizumab | Drug | 7.5mg/kg，iv drip，d1, q3w |
|
| Oxaliplatin | Drug | 130mg/m2，iv drip for 2h，d1, q3w |
|
| Capecitabine | Drug | 1000mg/m2 twice daily, d1-14, q3w |
|
| S-1 | Drug | 40~60mg Bid，d1~14, q3w |
|
| One year progression-free survival (PFS) | 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) | 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. |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000632826 | sintilimab |
| D000068258 | Bevacizumab |
| D000077150 | Oxaliplatin |
| D000069287 | Capecitabine |
| C079198 | S 1 (combination) |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
Not provided
Not provided