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ATDTT: Adjuvant Treatment of Digestive Tract Tumors

Sponsor
Xijing Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05742620
Collaborator
(none)
100
Enrollment
1
Arm
73
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Follow-up and Registration Study of Anlotinib Combined With Adjuvant Chemotherapy in the Treatment of Locally Advanced Gastrointestinal Tumors
Anticipated Study Start Date :
Jun 20, 2023
Anticipated Primary Completion Date :
Jul 20, 2026
Anticipated Study Completion Date :
Jul 20, 2029

Arms and Interventions

Arm Intervention/Treatment
Experimental: anlotinib+CAPEOX/SOX

Adjuvant treatment of locally advanced gastric cancer and colorectal cancer

Drug: anlotinib+CAPEOX/SOX
Patients with colorectal cancer use the anlotinib+CAPEOX protocol, and patients with gastric cancer use the anlotinib+SOX protocol. Anlotinib: 12mg, administered once a day on day 1-14, taken about half an hour before breakfast (the time of daily administration should be the same as much as possible), delivered with warm water, repeated once every three weeks; CAPEOX: capecitabine 1000mg/m2 each time, oral, twice a day, 1-14 days; Oxaliplatin: 130mg/m2 iv drip d1. SOX: Tegio: 100mg/day, continuous medication for 2 weeks, stop for 1 week; Oxaliplatin: 130mg/m2 iv drip d1.
Other Names:
  • anlotinib+chemotherapy

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 3y-DFSR [3years]

      3-year Disease-free survival

    Secondary Outcome Measures

    1. DFS [3years]

      Disease free survival

    2. 3y-OSR [3years]

      3-year Overall Survival

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 1.18 years old ≤ age ≤ 75 years old, male or female;

      1. ECOG score 0~2 points;
      1. Patients with locally advanced gastric cancer and colorectal cancer after radical surgery (R0 resection);
      1. Gastric cancer: patients with stage III (pT1N3bM0, pT2N3M0, pT3N2-3M0, pT4aN1-3M0, pT4bN0-3M0);
      1. Colorectal cancer: patients with stage III (T any N+M0);
      1. Normal function of main organs
      1. 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.
      1. 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;
      1. Have experienced any anti-tumor treatment before surgery, including chemotherapy, radiotherapy and targeted drug treatment;
      1. Patients with contraindications to chemotherapy;
      1. Other malignant tumors in the past 3 years;
      1. 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);
      1. Uncontrolled hypertension (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg, despite the best drug treatment);
      1. 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);
      1. 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;
      1. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
      1. Pregnant or lactating women; Those with fertility who are unwilling or unable to take effective contraceptive measures;
      1. It is known that it will produce allergy, hypersensitivity or intolerance to the test drug and its excipients;
      1. 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;
      1. Subjects are known to have a history of abuse of psychotropic substances, alcohol or drug abuse;
      1. 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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Xijing Hospital

    Investigators

    • Study Chair: DeLiang Yu, Doctor, Ambulatory Surgery Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Xijing Hospital
    ClinicalTrials.gov Identifier:
    NCT05742620
    Other Study ID Numbers:
    • TQXB-GC-II-003
    First Posted:
    Feb 24, 2023
    Last Update Posted:
    Feb 24, 2023
    Last Verified:
    Feb 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Feb 24, 2023