Evaluating the Benefits of Personalized Traditional Chinese Medicine in Postoperative Treatment for Locally Advanced Colorectal Cancer

NCT06596343 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: TCM-1
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Locally Advanced Colorectal Cancer; Postoperative Adjuvant Therapy

Outcome Measures

Primary Outcomes (1)

• The incidence of grade III/IV adverse events

  According to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, adverse events (AEs) are graded on a scale from 1 to 5 based on severity: * Grade I: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; no intervention required. * Grade II: Moderate; minimal, local, or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADLs). * Grade III: Severe; medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicated; disabling; limiting self-care ADLs. * Grade IV: Life-threatening consequences; urgent intervention required. * Grade V: Death related to adverse event.

  From the beginning of the first chemotherapy to three months after the end of the course of chemotherapy

Secondary Outcomes (5)

• 3-year Disease-Free Survival

  3 years post-treatment

• 3-year Overall Survival

  3 years post-treatment

• Completion rate of adjuvant chemotherapy

  From the beginning of the first chemotherapy to the end of the course of chemotherapy, up to 6 months.

• European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30

  From the beginning of the first chemotherapy to three months after the end of the course of chemotherapy

• European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Colorectal Cancer Module （EORTC QLQ-CR29）

  From the beginning of the first chemotherapy to three months after the end of the course of chemotherapy

Study Arms (1)

Adjuvant Chemotherapy Combined with Traditional Chinese Medicine (TCM) Supportive Therapy

EXPERIMENTAL

Patients will sign an informed consent form after surgery but before starting chemotherapy, and those enrolled will receive a combination of chemotherapy and Traditional Chinese Medicine (TCM) supportive therapy. 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.

Drug: Adjuvant Chemotherapy Combined with Traditional Chinese Medicine (TCM) Supportive Therapy

Interventions

Adjuvant Chemotherapy Combined with Traditional Chinese Medicine (TCM) Supportive Therapy DRUG

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.

Adjuvant Chemotherapy Combined with Traditional Chinese Medicine (TCM) Supportive Therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.
• \. 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.
• \. 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.
• hour creatinine clearance rate ≥50 mL/min or serum creatinine ≤1.5 times ULN.

You may not qualify if:

• \. Colorectal cancer patients with distant metastasis as indicated by preoperative evaluation.
• \. Postoperative pathological results indicate that chemotherapy is not required according to the CSCO 2023 colorectal cancer guidelines.
• \. Patients who have received neoadjuvant chemoradiotherapy before surgery. 4. Patients with severe heart, liver, kidney damage, or bone marrow dysfunction.
• \. 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.

Sponsors & Collaborators

• Sir Run Run Shaw Hospital: lead

Study Sites (1)

Sir Run Run Shaw Hospital, Zhejiang University

Hangzhou, China, 310016, China

Location

Related Publications (5)

• Grothey A, Sobrero AF, Shields AF, Yoshino T, Paul J, Taieb J, Souglakos J, Shi Q, Kerr R, Labianca R, Meyerhardt JA, Vernerey D, Yamanaka T, Boukovinas I, Meyers JP, Renfro LA, Niedzwiecki D, Watanabe T, Torri V, Saunders M, Sargent DJ, Andre T, Iveson T. Duration of Adjuvant Chemotherapy for Stage III Colon Cancer. N Engl J Med. 2018 Mar 29;378(13):1177-1188. doi: 10.1056/NEJMoa1713709.

  PMID: 29590544 BACKGROUND

• Taghizadeh H, Prager GW. Personalized Adjuvant Treatment of Colon Cancer. Visc Med. 2020 Oct;36(5):397-406. doi: 10.1159/000508175. Epub 2020 Jun 29.

  PMID: 33178737 BACKGROUND

• Sauer S, Reed DR, Ihnat M, Hurst RE, Warshawsky D, Barkan D. Innovative Approaches in the Battle Against Cancer Recurrence: Novel Strategies to Combat Dormant Disseminated Tumor Cells. Front Oncol. 2021 Apr 27;11:659963. doi: 10.3389/fonc.2021.659963. eCollection 2021.

  PMID: 33987095 BACKGROUND

• Nelson H, Petrelli N, Carlin A, Couture J, Fleshman J, Guillem J, Miedema B, Ota D, Sargent D; National Cancer Institute Expert Panel. Guidelines 2000 for colon and rectal cancer surgery. J Natl Cancer Inst. 2001 Apr 18;93(8):583-96. doi: 10.1093/jnci/93.8.583.

  PMID: 11309435 BACKGROUND

• Siegel RL, Wagle NS, Cercek A, Smith RA, Jemal A. Colorectal cancer statistics, 2023. CA Cancer J Clin. 2023 May-Jun;73(3):233-254. doi: 10.3322/caac.21772. Epub 2023 Mar 1.

  PMID: 36856579 BACKGROUND

MeSH Terms

Interventions

Medicine, Chinese Traditional; Palliative Care

Intervention Hierarchy (Ancestors)

Medicine, East Asian Traditional; Medicine, Traditional; Complementary Therapies; Therapeutics; Patient Care; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Zhangfa Song

CONTACT

+86 13867421652; songzhangfa@zju.edu.cn

Engeng Chen

CONTACT

+86 15258672303; chenengeng@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 8, 2024
• First Posted: September 19, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)