Adjuvant Treatment of Digestive Tract Tumors

Launched by XIJING HOSPITAL · Feb 15, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at how well a new treatment works for patients with locally advanced gastric cancer and colorectal cancer after they have had surgery to remove the tumors. The goal is to see if combining a medication called anlotinib with standard chemotherapy can help more patients stay cancer-free for at least three years after their surgery.

To participate in this study, individuals need to be between 18 and 75 years old and must have had surgery for their cancer that successfully removed all visible disease. They should also not have any other serious health issues or recent treatments that could interfere with the study. Participants will be closely monitored throughout the trial, and all will need to provide informed consent, meaning they agree to take part after understanding what the study involves. This trial is not yet recruiting participants, but if you or someone you know is interested, it could be a way to access new treatment options while contributing to cancer research.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1.18 years old ≤ age ≤ 75 years old, male or female;
• • 2. ECOG score 0\~2 points;
• • 3. Patients with locally advanced gastric cancer and colorectal cancer after radical surgery (R0 resection);
• • 4. Gastric cancer: patients with stage III (pT1N3bM0, pT2N3M0, pT3N2-3M0, pT4aN1-3M0, pT4bN0-3M0);
• • 5. Colorectal cancer: patients with stage III (T any N+M0);
• • 6. Normal function of main organs
• • 7. Female subjects of childbearing age must carry out a serum pregnancy test within 3 days before starting the study medication, and the result is negative, and are willing to use a medically approved effective contraceptive measure (such as intrauterine device, contraceptive or condom) during the study period and within 3 months after the last administration of the study medication; For male subjects whose partners are women of childbearing age, they should undergo surgical sterilization or agree to use effective methods of contraception during the study and within 3 months after the last study administration.
• • 8. Subjects voluntarily joined the study and signed the informed consent form, with good compliance and cooperation in follow-up.
• Exclusion Criteria:
• • 1. Postoperative distal metastasis or failure to achieve R0 resection;
• • 2. Have experienced any anti-tumor treatment before surgery, including chemotherapy, radiotherapy and targeted drug treatment;
• • 3. Patients with contraindications to chemotherapy;
• • 4. Other malignant tumors in the past 3 years;
• • 5. Clinically obvious bleeding symptoms or obvious bleeding tendency (such as gastrointestinal bleeding, gastric ulcer bleeding, gastrointestinal bleeding, hemorrhagic gastric ulcer, stool occult blood++or above the baseline, or vasculitis);
• • 6. Uncontrolled hypertension (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg, despite the best drug treatment);
• • 7. People newly diagnosed with angina pectoris within 3 months before screening or suffering from serious cardiovascular diseases within 6 months before screening, including unstable angina pectoris or myocardial infarction; Arrhythmias (including QTcF: male ≥ 450 ms, female ≥ 470 ms) require long-term use of antiarrhythmic drugs; ≥ Grade 2 congestive heart failure (NYHA classification);
• • 8. Severe infection (such as the need for intravenous drip of antibiotics, antifungal or antiviral drugs) occurred within 4 weeks before the first administration, or fever of unknown cause occurred during screening/before the first administration\>38.5 ° C;
• • 9. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
• • 10. Pregnant or lactating women; Those with fertility who are unwilling or unable to take effective contraceptive measures;
• • 11. It is known that it will produce allergy, hypersensitivity or intolerance to the test drug and its excipients;
• • 12. Subjects who are participating in other clinical studies or whose first medication is less than 4 weeks from the end of the previous clinical study (the last medication), or who have 5 half-lives of the study drug;
• • 13. Subjects are known to have a history of abuse of psychotropic substances, alcohol or drug abuse;
• • 14. The researcher believes that there are any conditions that may harm the subject or cause the subject to fail to meet or perform the research requirements.