gastrointestinal tumors
Conditions
Interventions
Colorectal cancer experimental group:JS015 plus bevacizumab in combination with chemotherapy
Gastric cancer experimental group:JS015 plus Toripalimab in combination with chemotherapy
Sponsors
Shanghai East Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years (males and females) 2. Inclusion Criteria: a) Cohort 1 (First-line Treatment for Colorectal Cancer): Histopathologically confirmed unresectable recurrent or metastatic colon adenocarcinoma or rectal adenocarcinoma. Microsatellite stability: pMMR or MSS. No prior systemic anti-tumor treatment for recurrent or metastatic colon or rectal adenocarcinoma. For patients who have received neoadjuvant or adjuvant therapy, the time between the last treatment and recurrence or progression must exceed 12 months. b) Cohort 2 (First-line Treatment for Gastric Cancer): Histologically or cytologically confirmed unresectable locally advanced, recurrent, or metastatic gastric adenocarcinoma or gastroesophageal junction adenocarcinoma. HER2 negative as per testing results. No prior systemic anti-tumor treatment. For patients who have received neoadjuvant or adjuvant therapy, the time between the last treatment and recurrence or progression must exceed 6 months. 3. ECOG score of 0-1; 4. Expected survival =12 weeks. 5. At least one measurable lesion according to RECIST 1.1 criteria. 6. Good major organ function meeting the following requirements; 7. Subjects with reproductive potential, both females and males, must agree to use effective contraception during the study and for 6 months after the last dose. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 7 days prior to the first dose and must not be breastfeeding. 8. Ability to provide signed informed consent, including compliance with the requirements and restrictions listed in the informed consent form (ICF) and the study protocol.
Exclusion criteria
Exclusion criteria: 1. Leptomeningeal metastasis or active brain metastasis. 2. Presence of pleural effusion, peritoneal effusion, or pericardial effusion that requires repeated treatment (e.g., puncture or drainage). 3. A history of immunodeficiency, including positive human immunodeficiency virus (HIV) test, or known history of allogeneic organ transplant or allogeneic hematopoietic stem cell transplant. 4. Severe cardiovascular or cerebrovascular diseases. 5. Severe infection (CTCAE 5.0 grade >2) requiring hospitalization, such as severe pneumonia, bacteremia, or infection with complications, occurring within 28 days prior to the first study treatment. 6. Active tuberculosis, hepatitis B, or hepatitis C. 7. The patient has had other malignancies, except for subjects who have undergone curative treatment and have no known active disease for more than 5 years and are at low risk for recurrence (e.g., adequately treated basal cell carcinoma or squamous cell carcinoma of the skin). 8. Known peripheral neuropathy > Grade 1. 9. Active or previously recorded inflammatory bowel disease (e.g., Crohn’s disease or ulcerative colitis); inability to swallow; malabsorption syndrome; or uncontrolled nausea, vomiting, diarrhea, or other gastrointestinal conditions that could severely affect drug administration and absorption. 10. Cohort 1 (First-line Treatment for Colorectal Cancer) Exclusion Criteria: a. Tumor wrapping around major blood vessels or showing significant necrosis or cavitation as shown by imaging during the screening period, which, in the investigator’s opinion, may pose a bleeding risk. b. Clinical signs or symptoms of intestinal obstruction and/or gastrointestinal obstruction, including incomplete obstruction related to the underlying disease within 6 months prior to the first dose of study treatment. However, if surgical treatment has been performed and the obstruction has been fully resolved, screening may proceed. Screening is not allowed if the patient had a previous intestinal stent placement, and the stent remains in place during the screening period. c. Presence of severe, unhealed, or dehiscent wounds, active ulcers, or untreated fractures. d. Occurrence of significant clinically relevant bleeding symptoms or a clear bleeding tendency within 1 month prior to the first dose of study treatment, such as clinically significant hemoptysis (=1/2 teaspoon), gastrointestinal bleeding, or tumor bleeding. e. Poorly controlled hypertension (systolic blood pressure =150 mmHg and/or diastolic blood pressure >100 mmHg), or history of hypertensive crisis or hypertensive encephalopathy. f. Occurrence of abdominal or tracheoesophageal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to the first dose of study treatment. 11. Cohort 2 (First-line Treatment for Gastric Cancer): Active autoimmune diseases requiring systemic treatment (such as corticosteroids or immunosuppressive drugs) within 2 years prior to the first dose of study; 12. History of interstitial lung disease or non-infectious pneumonitis requiring corticosteroid treatment, or evidence of active pneumonitis shown by imaging during the screening period. 13. Unresolved toxicities from prior anti-tumor treatments that have not recovered to = Grade 1 per CTCAE 5.0 or to levels specified in the inclusion/exclusion criteria. 14. Cohort 2 (First-line Treatment for Gastric Cancer): Prior treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs, or drugs targ
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of Response;Disease control rate;Progression-free survival;Overall survival;Safety; | — |
Countries
China
Contacts
Public ContactYong Gao
Shanghai East Hospital
Outcome results
None listed