Efficacy and safety of total neoadjuvant therapy for locally advanced rectal cancer

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300075583

Enrollment

Unknown

Registered

2023-09-08

Start date

2023-09-01

Completion date

Unknown

Last updated

2023-09-11

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

Conditions

colorectal cancer

Interventions

Study group:Total Neoadjuvant Therapy

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1)18-75 years of age; (2)Histologically confirmed rectal cancer; (3)Imagimaging suggested locally advanced middle-low rectal cancer; (4)ECOG performance status =1; (5)No previous cancer therapy; (6)Meet the following hematologic criteria: ? Neutrophil count =1.5*10^9/L; ? Hemoglobin =10g/dL; ?Platelet count =100*10^9/L; (7)Meeting the following biochemical indicators: ?Total bilirubin =1.5*The upper limit of normal (ULN); ?AST or ALT<1.5*ULN; ?Creatinine clearance rate=60ml/min; (8)Patients of childbearing age should take appropriate protective measures before and in the experiment; (9)Signed informed consent; (10)Be able to follow the research plan and follow-up process; (11)Estimated survival time of over 3 years.

Exclusion criteria

Exclusion criteria: (1)Received cancer therapy within previous 3 months; (2)Patients with active bacterial or fungal infection; (3)Patients with HIV infection,HCV infection,uncontrollable coronary heart disease or Asthma,uncontrollable cerebrovascular disease and other diseases considered by researchers not to be included; (4)Pregnancy, breast-feeding women,women of childbearing age must have a negative pregnancy test within 7 days of enrolling; (5)Drug abuse, clinical or psychological or social factors that affect informed consent or research implementation; (6)Patients who may be allergic to the drugs used; (7)Patients who cannot undergo radiotherapy or chemotherapy due to social or geographical factors; (8)Significant weight loss (=10% weight loss) within the first 6 weeks of enrollment; (9)Any uncertainty affecting the patient's safety or compliance.

Design outcomes

Primary

Measure	Time frame
Pathological Complete Response;Objective Response Rate;	—

Secondary

Measure	Time frame
Progression-Freesurvival;Median Survival Time;Tumor Regression Grade;	—

Countries

China

Contacts

Public ContactQian Xiaoping

Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School

qianxiaoping211@hotmail.com+86 139 5174 3162

Outcome results

None listed

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