An interventional study of Transarterial infusion chemotherapy (TAIC) and Intravenous Chemotherapy（IVC） in Unresectable Colorectal Cancer, sponsored by Guang'anmen Hospital of China Academy of Chinese Medical Sciences. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by Guang'anmen Hospital of China Academy of Chinese Medical Sciences · Not applicable, Interventional, and Treatment
This is a prospective, multicenter, randomized, open-label clinical trial. It aims to investigate whether intensive transarterial infusion chemotherapy (TAIC) followed by sequential intravenous chemotherapy (IVC) is clinically more effective than IVC alone in the treatment of unresectable colorectal cancer (uCRC).
CRC is the third leading cause of new cancer cases and the second leading cause of cancer-related deaths worldwide. Current therapeutic modalities for CRC include surgical resection, IVC, radiotherapy, immunotherapy, targeted therapy, and their combinations. As a mainstream systemic treatment for CRC, IVC leads to widespread drug distribution but relatively low intratumoral drug accumulation. Compared with IVC, TAIC involves selective arterial catheterization to deliver chemotherapeutic agents directly to the tumor feeding vessels. Hepatic tumors receive their blood supply predominantly through branches of the hepatic artery. Hepatic artery infusion chemotherapy (HAIC) yields significantly superior outcomes compared to IVC and is currently widely employed for the treatment of primary and secondary hepatic malignancies. HAIC in combination with IVC can offer long-term durable disease control in the clinical treatment of liver cancer compared with IVC. CRC is also predominantly grown through angiogenesis. Therefore, we raise the question whether sequential IVC administered after intensive TAIC achieves better clinical efficacy than IVC alone for the treatment of uCRC. However, no prospective clinical trials have been conducted to compare the efficacy of these two strategies. This prospective study was therefore designed to fill this clinical knowledge gap. We hypothesize that intensive TAIC followed by sequential IVC yields superior clinical efficacy compared with IVC alone for the treatment of uCRC. This is a prospective, multicenter, randomized, open-label clinical trial. It aims to investigate whether intensive TAIC followed by sequential IVC is clinically more effective than IVC alone in the treatment of uCRC. Eligible patients will be randomly allocated into two groups upon enrolment: the intervention group (TAIC group) and the control group (IVC group). Patients will be randomly assigned at a 1:1 ratio with no blinding implemented. Randomization will be conducted by an independent trial statistician via a secure system with complete allocation concealment using the permuted block randomization method. Stratification factors consist of primary tumor location, presence of liver metastases, RAS/BRAF mutational status, and participating study center. Patients in the control group will receive FOLFOX-based IVC every 2 weeks for a total duration of 8 weeks. Patients in the TAIC group will receive FOLFOX-based TAIC at Week 0 and Week 4 and receive FOLFOX-based IVC at Week 2 and Week 6. For patients with CRLM, targeted agent selection is determined based on the RAS and BRAF mutational status and the primary tumor location. The primary endpoint is ORR. The secondary endpoints include Quality-of-life (QoL), clinical complete response (cCR) rate, pathological complete response (pCR) rate, the rate of conversion to resection (CTR), overall survival (OS), progression-free survival (PFS), and AEs. Primary and secondary efficacy analyses will be conducted for both the intention-to-treat (ITT) population and the per-protocol (PP) population. Safety analyses will be based on patients who received at least one dose of the assigned study treatment. Categorical variables will be presented as counts and percentages, while continuous variables will be presented as means with standard deviations or medians with interquartile ranges, as appropriate. Pearson's chi-square test or Fisher's exact test will be used for between-group comparisons of categorical variables. Continuous variables will be compared using Student's t-test or the Mann-Whitney U test as appropriate. Longitudinal QoL scores will be analyzed using linear mixed-effects models for repeated measurements, which naturally accommodate missing data under the missing at random assumption. For time-to-event endpoints of OS and PFS, the Kaplan-Meier method and Cox proportional hazards regression analysis will be applied. Between-group survival differences will be assessed using the log-rank test. Hazard ratios (HRs) with 95% confidence intervals (CIs) will be estimated from Cox regression models. All statistical tests will be two-sided, and a P value \< 0.05 will be considered statistically significant. All statistical analyses will be performed using the current version of R software. Patients in the IVC group will receive FOLFOX-based IVC every 2 weeks for a total duration of 8 weeks. The FOLFOX regimen consists of oxaliplatin (85 mg/m²) and leucovorin (400 mg/m²), each administered as a 2-hour intravenous infusion, and fluorouracil (2400 mg/m²) administered as a 44-hour continuous intravenous infusion.
For patients with CRLM, targeted therapy will be selected according to RAS/BRAF status and primary tumor side. Cetuximab will be administered by intravenous injection for the treatment of RAS/BRAF wild-type left-sided CRLM. Bevacizumab will be administered by intravenous injection for the treatment of RAS/BRAF wild-type right-sided CRLM and RAS/BRAF mutant CRLM irrespective of primary tumor location. Patients in the TAIC group will receive FOLFOX-based TAIC at Week 0 and Week 4 and receive FOLFOX-based IVC at Week 2 and Week 6. The FOLFOX-based TAIC consists of oxaliplatin (85 mg/m²) and leucovorin (400 mg/m²), each administered as a 2-hour transarterial infusion, and fluorouracil (2400 mg/m²) administered as a 44-hour continuous transarterial infusion. The IVC and targeted therapy regimens are the same as those in the IVC group. The dosage-calculation strategies of anticancer drugs, drug exposure and infusion durations, and supportive care, including symptom management and prevention of complications, do not differ significantly between TAIC and IVC groups. Treatment will be continued until disease progression (PD), unacceptable toxicity, or surgical resection. Prior to each TAIC procedure, the right femoral artery will be punctured using the Seldinger technique according to tumour vascular supply. A microcatheter will be advanced into the tumour-feeding branch of the superior mesenteric artery, inferior mesenteric artery or internal iliac artery. Chemotherapeutic agents will be administered through the microcatheter.
6,541 studies on the registry are indexed under Colorectal Neoplasms; 1,667 are open to participants now.
This study's planned enrollment of 50 is below the median of 76 across 4,800 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Guang'anmen Hospital of China Academy of Chinese Medical Sciences is the lead sponsor of 137 studies on the registry; 37 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Study population:
Patients who meet all inclusion criteria and none of the exclusion criteria are eligible for enrolment and study treatment.
Inclusion criteria:
Exclusion criteria:
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.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
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.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
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.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients in the TAIC group will receive FOLFOX-based TAIC at Week 0 and Week 4 and receive FOLFOX-based IVC at Week 2 and Week 6. The FOLFOX-based TAIC consists of oxaliplatin (85 mg/m²) and leucovorin (400 mg/m²), each administered as a 2-hour transarterial infusion, and fluorouracil (2400 mg/m²) administered as a 44-hour continuous transarterial infusion. Before placing a microcatheter into the feeding artery of the CRC, transarterial chemoembolization is performed for the liver metastases in patients with CRLM. The iodized oil emulsion is prepared by mixing 4 mL of iodized oil with 20 mg of oxaliplatin powder. Through the microcatheter, 0.5 mL of the iodized oil emulsion is slowly injected into the liver tumors via the feeding arterial branches. The technical endpoint of embolization is the absence of additional tumor staining or stasis/near stasis of the tumor-feeding arteries. The IVC and targeted therapy regimens are the same as those in the IVC group.
Procedure: Transarterial infusion chemotherapy (TAIC)
Patients in the IVC group will receive FOLFOX-based IVC every 2 weeks for a total duration of 8 weeks. The FOLFOX regimen consists of oxaliplatin (85 mg/m²) and leucovorin (400 mg/m²), each administered as a 2-hour intravenous infusion, and fluorouracil (2400 mg/m²) administered as a 44-hour continuous intravenous infusion. For patients with CRLM, targeted therapy will be selected according to RAS/BRAF status and primary tumor side. Cetuximab will be administered by intravenous injection for the treatment of RAS/BRAF wild-type left-sided CRLM. Bevacizumab will be administered by intravenous injection for the treatment of RAS/BRAF wild-type right-sided CRLM and RAS/BRAF mutant CRLM irrespective of primary tumor location.
Procedure: Intravenous Chemotherapy（IVC）
TAIC can increase the local intra-tumoral concentrations of chemotherapeutic agents by intensifying drug delivery into the tumor via super-selective catheterization of the tumor-feeding artery, and meanwhile reduce systematic toxicity.
Intravenous administration of chemotherapeutic agents is the mainstay of chemotherapy.
Objective response rate
Objective response rate is defined as the percentage of patients achieving complete response (CR) or partial response (PR) according to the Response Evaluation Criteria in Solid Tumor (RECIST) 1.1 for CRC and modified RECIST criteria for CRLM.
Time frame: 8 weeks
Health-related quality of life
Health-related quality of life was assessed using the European Organization for Research and Treatment of Cancer (EORTC) 30-item QoL Questionnaire (EORTC QLQ-C30). The EORTC QLQ-C30 consists of 30 items covering five functioning scales (physical, social, emotional, role, and cognitive), nine symptom scales (fatigue, nausea/vomiting, pain, dyspnea, sleep disturbances, appetite loss, constipation, diarrhea, and financial impact), and a global health status scale. Referring to a recall period of one-week (except for physical function, which does not refer to a recall period at all), patients indicate their answers on a 4-point Likert scale. Linear converted scale scores range from 0 to 100. Higher scores on the functioning scales and on the global health status scale indicate better functioning, whereas higher scores on the symptom scales indicate greater symptom burden.
Time frame: 8 weeks
Clinical complete response
Clinical complete response is defined as no visible tumor on imaging examination.
Time frame: 8 weeks
Pathological complete response
The pathological complete response is defined as the absence of invasive neoplastic cells upon microscopic examination of the tumor during surgery.
Time frame: 8 weeks
The rate of conversion to resectable status
Assessment of resectability represents a complex biological and technical decision; definitions of resectability vary substantially and are contingent on technical expertise, institutional surgical volume, institutional experience, and access to multidisciplinary oncological care. For the present clinical trial, the following resectability criteria will be applied: (i) Following 4 cycles of conversion therapy, simultaneous or staged complete surgical resection of the primary tumor and liver metastases can be performed. (ii) The primary lesion can be resected en bloc with R0 margins. (iii) Liver metastases can be treated with radical ablation alone or combined with radical surgical resection to achieve R0 margins; the future liver remnant constitutes no less than 30%-40% of the total liver volume. (iv) Patients maintain acceptable general status and have no additional distant metastases precluding local radical treatment. (v) Regional lymph node metastases are amenable to complete surg
Time frame: 8 weeks
Overall survival
Overall survival is calculated from the date of randomisation until death. Participants who are alive at the time of analysis were censored at the date of the latest time seen alive.
Time frame: 3 years
Progression-free survival
PFS is defined as the time from randomization to progression or death.
Time frame: 3 years
Adverse events
Adverse events (AEs) include chemotherapy-related and catheter-related complications, which will be graded in accordance with the National Cancer Institute Common Terminology Criteria for AEs, version 6.0.
Time frame: 8 weeks
Plan to share: Undecided — At present, this study remains in the active implementation phase. Given that individual participant data (IPD) contains sensitive personal privacy information of research subjects, the investigators will not share the IPD with external researchers temporarily, in order to strictly comply with ethical requirements and fully protect the legitimate rights and interests of study participants.
Started Mar 2026 (actual). Primary completion is estimated for Dec 2027, 21 months after the start.
Of 898 non-industry interventional studies with no phase under Colorectal Neoplasms, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 62. This study's planned 21 months is below that.
Counting every sponsor, half of 955 studies reached it within 32 months; a quarter within 14 and three quarters within 60.
How these figures are worked out, and which studies are left out of them.
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