To evaluate the efficacy and safety of PEG-rhG-CSF in oral chemotherapy containing regimen in patients with digestive tract tumors

Single-center, open, and controlled clinical studies evaluated the efficacy and safety of PEGylated recombinant human granulocyte stimulating factor injection in an oral chemotherapy regimen in patients with digestive tract tumors

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100054854

Enrollment

Unknown

Registered

2021-12-28

Start date

2022-01-01

Completion date

Unknown

Last updated

2022-12-12

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

Conditions

Neutropenia due to chemotherapy

Interventions

Experimental group:PEG-rhG-CSF was used 24 h after chemotherap

Control group:PEG-rhG-CSF was not used after chemotherapy

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients with oesophageal cancer, gastric cancer or colorectal cancer confirmed by pathological histology or cytology; 2. Aged >= 18 years, gender is not limited;; 3. ECOG score 0~2, estimated survival is more than 3 months; 4. The patient plans to receive a combination regimen containing Capecitabine or Tegio; 5. Main organs have normal function and meet the following standards: (1) The bone marrow hematopoietic function is normal, with no tendency to bleed; (2) Routine blood inspection meets: Hb >= 80 g/L; ANC >= 1.5 x 10^9/L; PLT >= 80 x 10^9/L; (3) Liver function and biochemical examination shall meet the following standards: those without liver metastasis, ALT and AST <= 2.5 x ULN; those with liver metastases, ALT and AST <= 5.0 x ULN; TBIL <= 1.5 x ULN; and blood creatinine <= 1.5 x ULN; (4) No serious heart or pulmonary dysfunction; 7. The pregnancy test (serum) result of women of childbearing age was negative, and willing to use appropriate methods for contraception during the test; 8. Volunteer to participate in this clinical trial, understand the research procedures, and be able to sign a written informed consent form.

Exclusion criteria

Exclusion criteria: 1. Infection currently difficult to control; or systemic antibiotics within 72h before chemotherapy; 2. Previous suffering from other malignant tumors were not cured; 3. Allergy to this product or other genetically engineered E. coli-derived biological products; 4. Patients suffering from mental or neurological diseases and unable to cooperate; 5. Pregnant or lactating women; 6. The researchers found it unfit for the participants.

Design outcomes

Primary

Measure	Time frame
Neutrophil number;	—

Secondary

Measure	Time frame
Antibiotic usage;	—

Countries

China

Contacts

Public ContactZhao Jun

Changzhi People's Hospital

zhaojun380@163.com+86 13835578500

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 16, 2026