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An observational study for the efficacy of apatinib combined with preoperative chemoradiotherapy for locally advanced rectal cancer

An observational study for the efficacy of apatinib combined with preoperative chemoradiotherapy for locally advanced rectal cancer

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900024689
Enrollment
Unknown
Registered
2019-07-21
Start date
2019-08-01
Completion date
Unknown
Last updated
2019-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal cancer

Interventions

case series:Apatinib combined with radiotherapy and chemotherapy

Sponsors

The First Affiliated Hospital of Suzhou University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Male or female patient: 18-75 years old; 2. The preoperative biopsy case is diagnosed as rectal cancer; 3. Imaging examination indicates that the tumor infiltration depth T3-4 or (and) any T N1-2 is not accompanied by distant metastasis; 4. Middle and low rectal cancer, the lower edge of the tumor is = 6 months; 8. The main organs function normally; 9. Sign the informed consent form; 10. Compliance is good, and the family agrees to cooperate with the follow-up.

Exclusion criteria

Exclusion criteria: 1. Patients who have previously received anti-VEGF or EGFR drugs; 2. TME surgery contraindications; 3. Participated in other drug clinical trials within four weeks; 4. Have multiple factors affecting oral medications (such as inability to swallow, chronic diarrhea, and intestinal obstruction); 5. Those who have high blood pressure and are not well controlled by antihypertensive medication (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg); 6. Urine routine indicates that urine protein >= ++ and confirmed 24-hour urine protein quantitation > 1.0 g; 7. Unhealed wounds or incompletely fractured fractures; 8. Coagulation dysfunction, with bleeding tendency (must be satisfied 14 days before randomization: INR is within normal range without anticoagulant); use anticoagulant or vitamin K antagonist such as warfarin, Patients treated with heparin or its analogues; use low-dose warfarin (1 mg orally, once daily) or low-dose aspirin for prophylactic purposes, with an international normalized ratio (INR) of 1.5 for prothrombin time (Do not exceed 100 mg per day); 9. In the past year, the occurrence of hyperactive/venous thrombosis, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis (except for those who have recovered from venous catheterization due to previous chemotherapy) and pulmonary embolism; 10. For female subjects: should be surgical sterilization, postmenopausal patients, or consent to use a medically approved contraceptive during the study treatment and 6 months after the end of the study treatment period; before the study was enrolled The serum or urine pregnancy test must be negative within 7 days and must be non-lactating. Male subjects: should be surgically sterilized, or consent to use a medically approved contraceptive during the study treatment and within 6 months after the end of the study treatment period. 11. Those who have a history of psychotropic substance abuse who are unable to quit or have a mental disorder; 12. Have a history of immunodeficiency, or have other acquired, congenital immunodeficiency diseases, or have a history of organ transplantation; 13. At the discretion of the investigator, there are serious concomitant diseases that compromise the safety of the patient or affect the patient's completion of the study.

Design outcomes

Primary

MeasureTime frame
Objective response rate;Tumor regression grade;

Countries

China

Contacts

Public ContactSongbing He

The First Affiliated Hospital of Suzhou University

20053835@qq.com+86 13812613662

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026