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This is a single-center, open phase II clinical trial to evaluate the tolerability, safety and efficacy of toriparib monotherapy in the treatment of locally advanced dMMR/MSI-H gastric or gastroesophageal junction adenocarcinoma.
In this phase II study, eligible patients are enrolled to receive toripalimab 240mg, ivdrip, Q3W to evaluate the anti-tumor efficacy and safety. After 2 and 4 cycles of toripalimab treatment, tumors are assessed, and patients are assigned to receive surgery or withdraw from study according to their anti-tumor efficacy. For patients withdrawing from study, routine treatment would be given. For patients staying in study, toripalimab would be administered for up to 2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PD-1 inhibitor | Experimental | Neoadjuvant therapy with PD-1 inhibitor (Toripalimab) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PD-1 inhibitor | Drug | 240mg, Q3W. The opportunity for surgery was evaluated after 2 cycles of treatment and surgical treatment was performed after 2-4 cycles of treatment. Postoperatively, adjuvant therapy was continued according to the neoadjuvant regimen, and direct treatment met the criteria for termination of treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Pathological complete remission (pCR) rates | Percentage of patients who achieve pathological complete remission (pCR) | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| R0 resection rates | The proportion of patients experiencing a R0 resection | 12 weeks |
| three-year disease-free survival rate, DFS | Percentage of patients who achieve disease-free survival lasting for more than three years |
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Inclusion Criteria:
1. Aged 18-75 years, regardless of gender 2. Patients with histologically or cytologically confirmed adenocarcinoma of the stomach or gastroesophageal junction and confirmed dMMR or MSI-H 3. Preoperative CT or MRI staging meeting the following criteria: T2 and above, with or without lymph node involvement, without clear distant metastasis 4. ECOG score of 0-1. 5. Expected survival ≥ 2 years. 6. Good organ function (no blood transfusion, no hematopoietic stimulating factor, no albumin or blood product transfusion within 14 days prior to the examination).
8.Be able to understand and willing to sign a written informed consent form.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dongsheng Zhang, PhD | Contact | 86-2087343795 | zhangdsh@sysucc.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Dongsheng Zhang, PhD | Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | China |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000082082 | Immune Checkpoint Inhibitors |
| C000656314 | toripalimab |
| ID | Term |
|---|---|
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000074322 | Antineoplastic Agents, Immunological |
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|
|
| 3 years |
| three-year Overall survival rate,OS | Percentage of patients who achieve survival for more than two years | 3 years |
| Incidence of Treatment-Related Adverse Events | Number of adverse events. | 3 years |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D000970 | Antineoplastic Agents |
| D045506 | Therapeutic Uses |