Clinical trial NCT05742620: Adjuvant Treatment of Digestive Tract Tumors
Official title: Follow-up and Registration Study of Anlotinib Combined With Adjuvant Chemotherapy in the Treatment of Locally Advanced Gastrointestinal Tumors
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Adjuvant Treatment
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2023-02-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the 3-year Disease-free survival rate(DFSR) of patients with locally advanced gastric cancer and colorectal cancer treated with anlotinib combined with adjuvant chemotherapy.

Detailed description: Gastrointestinal tumor has a high incidence rate and mortality, which is one of the major diseases that seriously endanger the health of Chinese residents. Postoperative recurrence of colorectal cancer is the main cause of death in patients with advanced colorectal cancer. It is reported that the local recurrence rate after radical resection of colorectal cancer is 1% - 17%, and the 5-year survival rate after reoperation for recurrent and metastatic colorectal cancer is only 5% - 30%. In addition, the 5-year survival rate of locally advanced gastric cancer after operation is only 30-40%.

The adjuvant treatment of locally advanced colorectal cancer and gastric cancer is still mainly radiotherapy and chemotherapy, and the research of anti-vascular targeted therapy combined with adjuvant chemotherapy for locally advanced colorectal cancer and gastric cancer is still under exploration. The research of antiangiogenic drugs combined with adjuvant chemotherapy in the treatment of locally advanced colorectal cancer and gastric cancer can fill this gap. Therefore, this study was designed to explore the efficacy and safety of antiangiogenic drugs combined with adjuvant chemotherapy in the treatment of locally advanced colorectal cancer and gastric cancer.

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.

Primary outcomes:
measure: 3y-DFSR
timeFrame: 3years
Secondary outcomes:
measure: DFS
timeFrame: 3years
measure: 3y-OSR
timeFrame: 3years
Other outcomes:
Locations:
Study officials:
affiliation: Ambulatory Surgery Center
name: DeLiang Yu, Doctor
role: STUDY_CHAIR
References:
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