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This is a Randomized, Double-Blind, Phase II/III Clinical Study of the Efficacy and Safety of Sintilimab Combined with Chemotherapy With or Without Ipilimumab N01 in Perioperative Treatment of Resectable Gastric/Gastroesophageal Junction Adenocarcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sintilimab | Active Comparator | Neoadjuvant Treatment period: up to 3 cycles of sintilimab plus chemotherapy in combination with Ipilimumab N01 prior to surgery. adjuvant Treatment period: Subjects will receive 5 cycles of sintilimab plus chemotherapy, and then receive sintilimab therapy after surgery until disease recurrence, unacceptable toxicity, receiving new anti-tumor therapy, withdrawal of informed consent (ICF), lost to follow-up or death, or other conditions that require treatment discontinuation (whichever occurs first). The maximum duration of postoperative treatment with either sintilimab or placebo is 13 cycles. |
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| Sintilimab+Ipilimumab N01 | Experimental | Neoadjuvant Treatment period: up to 3 cycles of sintilimab plus chemotherapy in combination with Ipilimumab N01 prior to surgery. adjuvant Treatment period: Subjects will receive 5 cycles of sintilimab plus chemotherapy, and then receive sintilimab therapy after surgery until disease recurrence, unacceptable toxicity, receiving new anti-tumor therapy, withdrawal of informed consent (ICF), lost to follow-up or death, or other conditions that require treatment discontinuation (whichever occurs first). The maximum duration of postoperative treatment with either sintilimab or placebo is 13 cycles. |
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| Sintilimab placebo+Ipilimumab N01 placebo | Active Comparator | Neoadjuvant Treatment period: up to 3 cycles of sintilimab placebo plus chemotherapy in combination with Ipilimumab N01 Placebo prior to surgery. adjuvant Treatment period: Subjects will receive 5 cycles of sintilimab placebo plus chemotherapy, and then receive sintilimab placebo therapy after surgery until disease recurrence, unacceptable toxicity, receiving new anti-tumor therapy, withdrawal of informed consent (ICF), lost to follow-up or death, or other conditions that require treatment discontinuation (whichever occurs first). The maximum duration of postoperative treatment with either sintilimab or placebo is 13 cycles. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tegafur, Gimeracil and Oteracil Potassium Capsules | Drug | 40mg/m2, D1-14 BID PO Q3W |
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| Measure | Description | Time Frame |
|---|---|---|
| Major Pathological Response (MPR) rate in Resectable Gastric/Gastroesophageal Junction Adenocarcinoma | The MPR rate is defined as the proportion of participants with a Tumor Regression Grade (TRG) score of 0 or 1 in the primary tumor after radical surgical resection following neoadjuvant therapy. | Up to approximately 6 weeks following the beginning of Post-operative Assessment baseline(up to Study 2 years ) |
| Event-Free Survival (EFS) | The EFS is defined as the time from randomization to the first occurrence of disease progression precluding curative resection, postoperative local recurrence, distant metastasis, or death from any cause. | Up to approximately 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| pathological Complete Response (pCR) rate | The pCR rate is defined as the proportion of participants with no residual viable tumor in both the primary tumor and lymph nodes after radical surgical resection following neoadjuvant therapy. | Up to approximately 6 weeks following the beginning of Post-operative Assessment baseline(up to Study 2 years ) |
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Inclusion Criteria
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chunxian Hu | Contact | +86 021 3183 7200 | chunxian.hu@innoventbio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Guangzhou | Guangdong | 510060 | China |
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| Sintilimab Placebo | Drug | 200 mg, D1 IV Q3W |
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| Sintilimab | Drug | 200mg D1 IV Q3W |
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| Ipilimumab N01 | Drug | 1mg/kg, D1 IV Q6W |
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| Oxaliplatin for injection | Drug | 130 mg/m2 D1 IV Q3W |
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| Ipilimumab N01 Placebo | Drug | 1mg/kg, D1 IV Q6W |
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| Clinical Down-staging Rate | Clinical downstaging rate refers to the proportion of participants with a reduction in clinical TNM (cTNM) stage after neoadjuvant therapy. | Up to approximately 6 weeks following the beginning of Post-operative Assessment baseline(up to Study 2 years ) |
| R0 resection rate | The R0 resection rate is defined as the proportion of participants who underwent R0 resection. | Up to approximately 6 weeks following the beginning of Post-operative Assessment baseline(up to Study 2 years ) |
| Overall survival (OS) | OS is defined as the time from randomization to death due to any cause. | Up to approximately 5 years |
| numbers of subjects with adverse events | defined as any untoward medical occurrence, whether or not there is a causal relationship with the study drug, in a clinical study subject from the time informed consent form is signed | Up to approximately 5 years |
| numbers of subjects with serious adverse events | Defined as any serious untoward medical occurrence, whether or not there is a causal relationship with the study drug, in a clinical study subject from the time informed consent form is signed | Up to approximately 5 years |
| ID | Term |
|---|---|
| D005641 | Tegafur |
| C104201 | gimeracil |
| C489337 | potassium oxonate |
| C000632826 | sintilimab |
| D000077150 | Oxaliplatin |
| D007267 | Injections |
| ID | Term |
|---|---|
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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