Trial Title:
Evaluating the Benefits of Personalized Traditional Chinese Medicine in Postoperative Treatment for Locally Advanced Colorectal Cancer
NCT ID:
NCT06596343
Condition:
Locally Advanced Colorectal Cancer
Postoperative Adjuvant Therapy
Conditions: Official terms:
Colorectal Neoplasms
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Adjuvant Chemotherapy Combined with Traditional Chinese Medicine (TCM) Supportive Therapy
Description:
1. Chemotherapy Regimen:
- Postoperative adjuvant chemotherapy: A dual-drug concurrent regimen will be
used, with each cycle lasting 21 days. On day 1 of each cycle, oxaliplatin will
be administered intravenously at a dose of 130 mg/m². From day 1 to day 14 of
each cycle, capecitabine will be taken orally at a dose of 1000 mg/m², twice
daily. The treatment duration will follow the CSCO 2023 guidelines for
colorectal cancer, with chemotherapy lasting for 6 months.
2. TCM Treatment:
- TCM treatment will be based on syndrome differentiation ("Zheng") and guided by
the Guidelines for TCM Diagnosis and Treatment of Malignant Tumors.
Arm group label:
Adjuvant Chemotherapy Combined with Traditional Chinese Medicine (TCM) Supportive Therapy
Summary:
This study aims to explore the role of Traditional Chinese Medicine (TCM) based on
syndrome differentiation in reducing chemotherapy side effects, lowering the risk of
metastasis and recurrence, and improving survival rates in postoperative colorectal
cancer patients through a prospective, single-arm interventional clinical trial.
Detailed description:
Colorectal cancer is the third leading cause of cancer-related deaths worldwide, with 1.9
million new cases and nearly 935,000 deaths reported in 2020. In China, colorectal cancer
ranks third in new cases for both men and women, while it ranks fifth in cancer-related
deaths among men and second among women. It has become a global public health issue and a
major threat to people's health. Surgical resection is the primary treatment for colon
cancer and can potentially cure the tumor. More than 50% of colon cancer patients are
diagnosed at locally advanced stages (stage II and III). Even after curative surgery,
about 50% of these patients experience tumor recurrence due to undetectable
micrometastases that persist post-surgery. Most of these patients require adjuvant
chemotherapy to eliminate micrometastases and improve cure rates. Postoperative adjuvant
chemotherapy can eradicate hidden micrometastases and prolong survival in colorectal
cancer patients. Large clinical trials have shown that adjuvant chemotherapy reduces the
recurrence rate by 41% and overall mortality by 33%. Thus, surgery combined with
postoperative adjuvant chemotherapy is the standard treatment approach to cure colon
cancer.
However, about 25% of stage III colorectal cancer patients still relapse despite adjuvant
chemotherapy, indicating that not all patients benefit from it. Additionally,
postoperative adjuvant chemotherapy can cause numerous side effects. The IDEA study
reported that grade 3 or higher chemotherapy-related toxicities occurred in 20% of
patients receiving 3 months of adjuvant chemotherapy and 36.9% of patients receiving 6
months. These side effects include mucositis, vomiting, diarrhea, febrile neutropenia,
fatigue, hair loss, hand-foot syndrome (pain, redness, and peeling of the skin on the
palms and soles), neurotoxicity, and cardiotoxicity. The incidence and severity of these
side effects vary depending on the specific drugs and administration methods, and some
side effects, such as oxaliplatin-induced peripheral neuropathy, can persist long-term,
significantly affecting patients' quality of life.
Thus, both healthcare providers and patients are seeking additional therapies to reduce
toxicity and improve the efficacy of standard treatment. In real-world practice, many
colorectal cancer patients have received Traditional Chinese Medicine (TCM) as part of
their postoperative care, and TCM plays a significant role in colorectal cancer
prevention and treatment.
In TCM, colorectal cancer is classified under conditions such as "zang du" (organ toxin),
"chang ji" (intestinal accumulation), and "ji ju" (mass accumulation), primarily caused
by irregular diet, emotional imbalance, and deficiency of vital energy (qi). Although the
disease originates in the intestines, it is closely related to the spleen, stomach,
liver, and kidneys. Early-stage disease is dominated by damp-heat and toxin stagnation,
while later stages are characterized by a deficiency of vital energy with excess
pathogenic factors, typically involving spleen and kidney yang deficiency, qi and blood
deficiency, or liver and kidney yin deficiency. A deficiency in vital energy and yin-yang
imbalance are key factors in the development of colorectal cancer. Damp-heat accumulation
in the intestines leads to stagnation of qi, toxin formation, and eventual mass
formation, which is a core mechanism of disease development.
This study aims to investigate the role of adding TCM during and after surgery and
chemotherapy to enhance the clinical efficacy of adjuvant chemotherapy, reduce the
occurrence of adverse effects, prevent metastasis and recurrence, and ultimately improve
survival rates.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
-
1. Age between 18 and 75 years. 2. Diagnosed with colorectal cancer at Sir Run Run
Shaw Hospital, Zhejiang University School of Medicine, and underwent standard
radical colorectal cancer surgery. Postoperative pathological staging is stage
III (AJCC 8th edition: T4, any N+, M0, or any T, N2, M0), indicating the need
for chemotherapy according to the CSCO 2023 colorectal cancer guidelines.
3. Willing to receive Traditional Chinese Medicine (TCM) treatment. 4. Voluntarily
agree to participate in the study and sign the informed consent form. If the
subject is unable to read or sign the consent due to incapacity, the informed
consent must be obtained from a legal guardian. If the subject cannot read the
consent (e.g., illiterate subjects), a witness must observe and sign the
consent process.
5. Expected survival of ≥12 months. 6. ECOG performance status score of 0-1. 7. No
prior anti-cancer, immunotherapy, or radiation treatment. 8. Laboratory tests
meeting the following criteria:
- White blood cell count ≥3.5 × 10^9/L, absolute neutrophil count ≥1.8 × 10^9/L,
platelet count ≥100 × 10^9/L, hemoglobin ≥100 g/L.
- INR ≤1.5 and APTT ≤1.5 times the upper limit of normal (ULN) or PTT ≤1.5 times ULN.
- Total bilirubin ≤1.25 times ULN; ALT and AST ≤3 times ULN; serum albumin ≥28 g/L.
- 24-hour creatinine clearance rate ≥50 mL/min or serum creatinine ≤1.5 times ULN.
Exclusion Criteria:
-
1. Colorectal cancer patients with distant metastasis as indicated by preoperative
evaluation.
2. Postoperative pathological results indicate that chemotherapy is not required
according to the CSCO 2023 colorectal cancer guidelines.
3. Patients who have received neoadjuvant chemoradiotherapy before surgery. 4.
Patients with severe heart, liver, kidney damage, or bone marrow dysfunction.
5. Pregnant or breastfeeding women. 6. Patients with known allergies to
Traditional Chinese Medicine components. 7. Patients who refuse chemotherapy or
TCM treatment. 8. Patients with a history of mental illness or cognitive
impairment.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Sir Run Run Shaw Hospital, Zhejiang University
Address:
City:
Hangzhou
Zip:
310016
Country:
China
Contact:
Last name:
Zhangfa Song
Phone:
+86 13867421652
Email:
songzhangfa@zju.edu.cn
Start date:
October 2024
Completion date:
September 30, 2027
Lead sponsor:
Agency:
Sir Run Run Shaw Hospital
Agency class:
Other
Source:
Sir Run Run Shaw Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06596343
