An observational study in Colorectal Cancer, sponsored by Wuhan University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-06-24.
Sponsored by Wuhan University · Observational
Fruquintinib is already the standard third-line treatment for metastatic colorectal cancer, but the efficacy of fruquintinib in neoadjuvant and conversion therapy for locally advanced/advanced colorectal cancer has not yet been reported. This study aims to observe the efficacy and safety of fruquintinib combined with chemotherapy in neoadjuvant or conversion therapy for colorectal cancer patients in the real world.
6,541 studies on the registry are indexed under Colorectal Neoplasms; 1,667 are open to participants now.
This study's planned enrollment of 70 is below the median of 250 across 1,440 observational studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Wuhan University is the lead sponsor of 46 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Colorectal cancer who have received chemotherapy and fruquintinib as neoadjuvant or conversion treatment.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients must meet all of the following criteria to be enrolled in this study:
Exclusion Criteria:
Patients meeting any of the following criteria are not eligible to enter the study:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Combination Product: corhot1: chemotherapy combined with fruquintinib
Combination Product: corhot2: chemotherapy combined with fruquintinib
Drug page: HMPL-013
Chemotherapy Drugs: Selection based on clinical guidelines/indications and patient condition.For example, recommended chemotherapy regimens: mFOLFOX6 or CAPEOX. Fruquintinib: 3mg (starting dose), PO (once daily). Dosing schedule and dosage can be adjusted based on concurrent chemotherapy and immune checkpoint inhibitors. Have received fruquintinib treatment for at least 2 cycles.
Drug page: HMPL-013
Chemotherapy Drugs: Selection based on clinical guidelines/indications and patient condition.For example, recommended chemotherapy regimens: mFOLFOX6 or CAPEOX. Fruquintinib: 3mg (starting dose), PO (once daily). Dosing schedule and dosage can be adjusted based on concurrent chemotherapy and immune checkpoint inhibitors. Have received fruquintinib treatment for at least 2 cycles.
Corhot1: Pathological Complete Response Rate (pCR)
Pathological Complete Response Rate (pCR), defined as no residual tumor cells in the surgical specimen of the primary tumor and lymph nodes (ypT0N0); corresponds to TRG grade 0.
Time frame: Time from the first treatment up to 12 weeks
Corhot2: R0 surgical conversion rate
R0 surgical conversion rate：The proportion of subjects who achieve complete R0 resection of both the primary gastric lesion and any metastases among all subjects receiving the conversion therapy regimen.
Time frame: Time from the first treatment up to 24 weeks
Corhot1: R0 resection rate
R0 resection rate: Defined as the proportion of subjects achieving negative margins among those who underwent surgical treatment.
Time frame: Time from the first treatment up to 12 weeks
Corhot1: Event-Free Survival (EFS)
Event-Free Survival (EFS): Time from initiation of neoadjuvant study treatment until first documented progression, recurrence/metastasis, or death from any cause (whichever occurs first, without progression/recurrence at the time of death).
Time frame: Time from the first treatment up to 2 years
Corhot1: 1-year Event-Free Survival (EFS) rate
1-year Event-Free Survival rate: Survival rate of patients who, from initiation of neoadjuvant study treatment, have not experienced progression, recurrence/metastasis, or death from any cause at 12 months.
Time frame: Time from the first treatment up to 12 months.
Corhot1 and Corhot2: Overall Survival (OS)
Overall Survival (OS): Time from the first study treatment until death from any cause.
Time frame: Time from the first treatment up to 2 years.
Corhot1 and Corhot2: 1-year Overall Survival (OS) rate
1-year OS rate: Survival rate of patients who have not experienced progression or death from any cause at 12 months from the first study treatment.
Time frame: Time from the first treatment up to 12 months.
Corhot1 and Corhot2: Objective Response Rate (ORR)
Objective Response Rate (ORR): Proportion of patients with target lesions who achieve a complete response (CR) or partial response (PR) among all treated patients.
Time frame: corhot1 ：Time from the first treatment up to 12 weeks. Corhot2：Time from the first treatment up to 2 years.
Corhot1 and Corhot2: Disease Control Rate (DCR)
Disease Control Rate (DCR): Proportion of patients with target lesions who achieve a complete response (CR), partial response (PR), or stable disease (SD) among all treated patients.
Time frame: corhot1 ：Time from the first treatment up to 12 weeks. Corhot2：Time from the first treatment up to 2 years.
Corhot2: Curative Surgery Conversion Rate
Curative Surgery Conversion Rate: The proportion of subjects who undergo potentially curative surgical resection of both the primary gastric lesion and any metastases among all subjects receiving the conversion therapy regimen.
Time frame: Time from the first treatment up to 24 weeks
Corhot2: Progression-Free Survival (PFS)
Progression-Free Survival (PFS): Defined as the time from initiation of the study treatment regimen until the first radiographic disease progression, postoperative disease recurrence, or death (whichever occurs first). This can be calculated separately for surgical and non-surgical patients, with surgical patients considering postoperative disease recurrence or death (whichever occurs first).
Time frame: Time from the first treatment up to 2 years.
Corhot1and Corhot2: Adverse events
Adverse events during neoadjuvant or conversion therapy, impact on surgery (delay, surgical complications) for corhot1, impact on surgical procedure and postoperative outcomes for corhot2.
Time frame: through study completion, an average of 1 year
Plan to share: No
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This study is not yet recruiting, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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Wuhan University