Colorectal Adenocarcinoma Metastatic in the LiverPhase 3PACHA-02NCT07284394
Liver-directed Chemotherapy After Surgery of Liver Metastases of Colorectal Cancer in Patients With High Risk of Recurrence of Their Disease
A Phase 3 study testing Arterial catheter infusion chemotherapy and IV Chemotherapy (Regimen 1) in people with Colorectal Adenocarcinoma Metastatic in the Liver and Colorectal Cancer, run by UNICANCER.
Trial summary
At the time of diagnosis, 25% of patients with colorectal cancer present with liver metastasis (CRLM). Among patients with localized colorectal cancer (Stages I-III), 50% to 70% will develop liver metastases during the course of their disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Adenocarcinoma Metastatic in the Liver, Colorectal Cancer
- What is being tested?
- Arterial catheter infusion chemotherapy and IV Chemotherapy (Regimen 1)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 272 participants
- Where
- No sites listed yet
- Study dates
- Jul 2026to Jan 2035
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient must have signed a written informed consent prior to any trial specific procedures. When the patient is physically unable to give their written consent, a trusted person of their choice, independent from the investigator or the sponsor, can confirm in writing the patient's consent
- Age > 18 years
- ECOG performance status 0-1
- Histologically confirmed stage IV pMMR CRC
- Resected CRLM by one- or two-stage procedures including reverse strategy
- Partial Response or Stability Disease (RECIST 1.1) to preoperative cytotoxic doublet or triplet IV chemotherapy +/- targeted agent before surgery
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- Curative-intent ( R0/R1 resection ± local ablation) surgery of 4 or higher CRLM
- No macroscopic residual (hepatic or extra-hepatic) disease on postoperative CT scan within 4 weeks after surgery confirmed during local multidisciplinary tumor board (except up to 3 lung nodules < 10 mm deemed amenable to curative-intent resection/local ablation and non-resected primary tumor with no or mild symptoms)
- Eligible to HAI of oxaliplatin by (permanent or selective) catheterization defined as the absence of medical (any contraindication to oxaliplatin administration, mainly residual peripheral sensory neuropathy grade < 2) and technical (vascular anatomy to perform HAI chemotherapy) contraindications to administer oxaliplatin-based doublet or triplet chemotherapy within 8 weeks from surgery during at least 4 cycles evaluated by interventional radiologist and medical oncologist
- Normal liver function (bilirubin < 1.5 x upper limit of normal values (ULN), aminotransferases < 5 ULN, alkaline phosphatase < 5 ULN, International normalized ratio (INR) < 1.5 ULN, platelets > 100,000/mm3)
- Women of childbearing potential must have a negative pregnancy test done within 30 days before randomisation
- Potentially reproductive patients must agree to use an effective contraceptive method or practice adequate methods of birth control or practice complete abstinence while on treatment, and for at least 6 months after the last dose of study drug
- Patients must be willing and able to comply with the protocol for the duration of the study including scheduled visits, treatment plan, laboratory tests and other study procedures
- Patients must be affiliated to a Social Security System (or equivalent)
Who cannot join
- Stage IV dMMR CRC
- Progressive Disease (RECIST 1.1) to preoperative cytotoxic doublet or triplet IV chemotherapy +/- targeted
- Incomplete (R2) surgery or residual (hepatic or extrahepatic) disease on postoperative CT scan within 4 weeks after surgery or symptomatic primary tumours in case of reverse strategy
- Extra hepatic metastasis disease, except ≤ 3 lung nodules < 10 mm deemed amenable to curative-intent resection/local ablation and non-resected primary tumor with no or mild symptoms
- Impossibility to receive at least 4 postoperative cycles with oxaliplatin
- Patients with contraindications for HAI or IV doublet or triplet administration as limiting anatomical variations of hepatic artery, peripheral sensory neuropathy ≥ grade 2 (NCI-CTAE v.5.0), gastric/duodenal ulcer or significant chronic liver disease (resulting in portal hypertension and/or liver failure)
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- Peripheral neuropathy grade ≥ 2
- Patient with a dihydropyrimidine dehydrogenase deficiency (DPD)
- Medical history of other concomitant or previous malignant disease, except adequately treated in situ carcinoma of the uterine cervix, basal or squamous cell carcinoma of the skin, or cancer in complete remission for ≥5 years
- Pregnant women or women who are breast-feeding
- Participation in another therapeutic trial within the 30 days prior to randomisation
- Patients unwilling or unable to comply with the medical follow-up required by the trial because of geographic, familial, social, or psychological reasons
- Persons deprived of their liberty or under protective custody or guardianship
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Postoperative Hepatic Arterial Chemotherapy After Resection of Colorectal Liver Metastases in Patients at High Risk of Recurrence
At the time of diagnosis, 25% of patients with colorectal cancer present with liver metastasis (CRLM). Among patients with localized colorectal cancer (Stages I-III), 50% to 70% will develop liver metastases during the course of their disease. Surgery in combination with intravenous (IV) chemotherapy represents the only chance of cure for selected patients by removing all liver metastases and treat residual microscopic disease by postoperative chemotherapy for 3 months. However, up to two-thirds of patients will experience a relapse, with about two-thirds of recurrences occurring in the liver.
Hepatic arterial infusion (HAI) chemotherapy has been proposed to improve the efficacy of chemotherapy by increasing the concentration of the drug in the liver. This treatment is currently administered by infusion through a specific catheter placed in the artery feeding the liver parenchyma, connected to a subcutaneous port-a-cath system. Several trials have shown that the administration of floxuridine or oxaliplatin via HAI combined with IV chemotherapy achieves a higher response rate compared to IV chemotherapy alone in patients with unresectable colorectal liver metastases. HAI chemotherapy has thus become an attractive therapeutic option for patients who underwent curative-intent surgery to reduce the risk of hepatic recurrence.
Read more
The investigators recently demonstrated in the PACHA-01 phase II randomized study a 47% decrease of hepatic recurrence risk by HAI of oxaliplatin compared to IV chemotherapy alone, despite a higher but manageable toxicity among 99 patients who underwent curative surgery considered at high risk of recurrence. Moreover, this study showed promising results in terms of time to recurrence and survival. Moreover, feasibility has improved in recent years with the development of non-invasive techniques for HAI.
The investigators propose to conduct the PACHA-02 trial to evaluate the efficacy in terms of disease-free survival of oxaliplatin administered via HAI in combination with IV chemotherapy after curative resection in patients with colorectal cancer at high risk of recurrence. A total of 272 patients who will undergo curative surgery for at least 4 CRLM with no residual disease on imaging performed within 4 weeks after surgery will be included. Patients will then be randomized to receive oxaliplatin-based chemotherapy either via HAI or IV combined with standard IV chemotherapy, every 2 weeks for at least 3 months.
The primary objective of this study will be to determine if the administration of oxaliplatin via HAI increases the time between treatment and disease recurrence compared to IV administration. The secondary objectives include overall survival, hepatic recurrence-free survival, safety, pattern of recurrence, and quality of life.
- Being tested
- Arterial catheter infusion chemotherapy, IV Chemotherapy (Regimen 1)
- Keywords
- hepatic arterial infusion chemotherapy, Colorectal cancer, Colorectal Liver metastases, High risk of recurrence, Surgery
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arterial catheter infusion chemotherapyDrug
HAI administration of chemotherapy
IV Chemotherapy (Regimen 1)Drug
IV administration of chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| HAI Arm | Experimental | Not described Receives: Drug: Arterial catheter infusion chemotherapy |
| IV Arm | Active comparator | Not described Receives: Drug: IV Chemotherapy (Regimen 1) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence-free survival (RFS)
Comparison between the two arms of recurrence-free survival (RFS), defined by the time between randomization and the occurrence of the first oncological event observed according to RECIST v1.1 criteria, such as local or metastatic recurrence or death from any cause
Measured: From date of randomization to the date of occurrence of the first oncological event, assessed up to 8.5 years
Secondary outcomes (8)
Overall survival (OS)
Overall survival (OS), defined as the time from randomization to death, irrespective of cause. Patients alive at the time of the analysis will be censored at last follow-up
Measured: from randomization to death from any cause, up to 3.5 years minimum
Hepatic recurrence-free survival (h-RFS)
Hepatic recurrence-free survival (h-RFS), defined as the time from randomization to the occurrence of the first hepatic relapse according RECIST 1.1 criteria or death, irrespective of cause. Patients alive without hepatic recurrence at the time of the analysis will be censored at last follow-up
Measured: From date of randomization to the date of occurrence of the first hepatic relapse, assessed up to 8.5 years
Patterns of recurrence
Patterns of recurrence, defined as hepatic recurrence rate and extra hepatic recurrence rate as first oncological event
Measured: Date of the first oncological event documented assessed up to 8.5 years
Feasibillity
Feasibillity, defined as:
- Proportion of patients receiving at least 4 cycles of oxaliplatin.
- Proportion of patients treated within 8 weeks after surgery accordingly to the attributed arm.
- Relative dose-intensity of oxaliplatin (calculated over the first three months of treatment).
Measured: From date of randomization up to 3 months after treatment start
Incidence of the HAI in adverse events
Safety assessed according to Common Terminology Criteria for Adverse Events (CTCAE v5.0) system for treatment toxicity. In HAI arm catheter-related complications and treatment procedures will be analyzed. AE will be coded with the MedDRA dictionary
Measured: From date of randomization up to 30 days after the last study treatment
Subsequent treatment description
Description of chemotherapy (IV, HAI, lines and cycles, curative intent) in case of recurrence
Measured: From date of first subsequent treatment to the date of the end of study, assessed up to 8.5 years
Tumor response rate
Tumor response rate according to RECIST 1.1 criteria following reintroduction of chemotherapy in case of recurrence
Measured: From the date of the first subsequent treatment to the date of the end of study, assessed up to 8.5 years
Quality of Life Questionnaire - Colorectal cancer associated with the Liver colorectal metastasis Module
This EORTC liver metastasis specific questionnaire QLQ-LMC21 (questions 31 to 51) is intended to supplement the QLQ-C30 (questions 1 to 30) to obtain a global score describing the quality of life of the patients
Measured: At baseline, 3 months then every 3 months for 3 years and every 6 months for the following 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study startJul 2026 (estimated)
- Primary completionJan 2031 (estimated)
- Study completionJan 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Adenocarcinoma Metastatic in the LiverStudies of the same condition, open and under way.
- More trials run by UNICANCERThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 272 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UNICANCER
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maximiliano GELLI, Dr, Principal investigator, Gustave Roussy, Département Anesthésie Chirurgie et Interventionnel (DACI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07284394
- Sponsor's protocol ID
- UC-GIG-2515
- Other IDs
- 2025-523913-27-00, 2025
- Acronym
- PACHA-02
- Status last verified
- May 2026
- First submitted
- 14 Nov 2025
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Hepatic Arterial Chemotherapy After Resection of Colorectal Liver Metastases in Patients at High Risk of Recurrence
- ClinicalTrials.gov ID
- NCT07284394
- Acronym / sponsor ID
- PACHA-02 / UC-GIG-2515
- Keywords
- hepatic arterial infusion chemotherapy, Colorectal cancer, Colorectal Liver metastases, High risk of recurrence, Surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 272 participants (estimated)
- Lead sponsor
- UNICANCERUniversity, hospital or other
- Study start
- Jul 2026 (estimated)
- Primary completion
- Jan 2031 (estimated)
- Study completion
- Jan 2035 (estimated)
- First posted
- 16 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
At the time of diagnosis, 25% of patients with colorectal cancer present with liver metastasis (CRLM). Among patients with localized colorectal cancer (Stages I-III), 50% to 70% will develop liver metastases during the course of their disease. Surgery in combination with intravenous (IV) chemotherapy represents the only chance of cure for selected patients by removing all liver metastases and treat residual microscopic disease by postoperative chemotherapy for 3 months. However, up to two-thirds of patients will experience a relapse, with about two-thirds of recurrences occurring in the liver.
Hepatic arterial infusion (HAI) chemotherapy has been proposed to improve the efficacy of chemotherapy by increasing the concentration of the drug in the liver. This treatment is currently administered by infusion through a specific catheter placed in the artery feeding the liver parenchyma, connected to a subcutaneous port-a-cath system. Several trials have shown that the administration of floxuridine or oxaliplatin via HAI combined with IV chemotherapy achieves a higher response rate compared to IV chemotherapy alone in patients with unresectable colorectal liver metastases. HAI chemotherapy has thus become an attractive therapeutic option for patients who underwent curative-intent surgery to reduce the risk of hepatic recurrence.
The investigators recently demonstrated in the PACHA-01 phase II randomized study a 47% decrease of hepatic recurrence risk by HAI of oxaliplatin compared to IV chemotherapy alone, despite a higher but manageable toxicity among 99 patients who underwent curative surgery considered at high risk of recurrence. Moreover, this study showed promising results in terms of time to recurrence and survival. Moreover, feasibility has improved in recent years with the development of non-invasive techniques for HAI.
The investigators propose to conduct the PACHA-02 trial to evaluate the efficacy in terms of disease-free survival of oxaliplatin administered via HAI in combination with IV chemotherapy after curative resection in patients with colorectal cancer at high risk of recurrence. A total of 272 patients who will undergo curative surgery for at least 4 CRLM with no residual disease on imaging performed within 4 weeks after surgery will be included. Patients will then be randomized to receive oxaliplatin-based chemotherapy either via HAI or IV combined with standard IV chemotherapy, every 2 weeks for at least 3 months.
The primary objective of this study will be to determine if the administration of oxaliplatin via HAI increases the time between treatment and disease recurrence compared to IV administration. The secondary objectives include overall survival, hepatic recurrence-free survival, safety, pattern of recurrence, and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HAI Arm | Experimental | Drug: Arterial catheter infusion chemotherapy |
| IV Arm | Active comparator | Drug: IV Chemotherapy (Regimen 1) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patient must have signed a written informed consent prior to any trial specific procedures. When the patient is physically unable to give their written consent, a trusted person of their choice, independent from the investigator or the sponsor, can confirm in writing the patient's consent
- Age > 18 years
- ECOG performance status 0-1
- Histologically confirmed stage IV pMMR CRC
- Resected CRLM by one- or two-stage procedures including reverse strategy
Key exclusion criteria (13 listed)
- Stage IV dMMR CRC
- Progressive Disease (RECIST 1.1) to preoperative cytotoxic doublet or triplet IV chemotherapy +/- targeted
- Incomplete (R2) surgery or residual (hepatic or extrahepatic) disease on postoperative CT scan within 4 weeks after surgery or symptomatic primary tumours in case of reverse strategy
- Extra hepatic metastasis disease, except ≤ 3 lung nodules < 10 mm deemed amenable to curative-intent resection/local ablation and non-resected primary tumor with no or mild symptoms
- Impossibility to receive at least 4 postoperative cycles with oxaliplatin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arterial catheter infusion chemotherapyHAI administration of chemotherapy | Drug | HAI Arm |
| IV Chemotherapy (Regimen 1)IV administration of chemotherapy | Drug | IV Arm |
Primary outcome
Recurrence-free survival (RFS)
Time frame: From date of randomization to the date of occurrence of the first oncological event, assessed up to 8.5 years
Comparison between the two arms of recurrence-free survival (RFS), defined by the time between randomization and the occurrence of the first oncological event observed according to RECIST v1.1 criteria, such as local or metastatic recurrence or death from any cause
8 secondary outcomes
Overall survival (OS)
Time frame: from randomization to death from any cause, up to 3.5 years minimum
Hepatic recurrence-free survival (h-RFS)
Time frame: From date of randomization to the date of occurrence of the first hepatic relapse, assessed up to 8.5 years
Patterns of recurrence
Time frame: Date of the first oncological event documented assessed up to 8.5 years
Feasibillity
Time frame: From date of randomization up to 3 months after treatment start
Incidence of the HAI in adverse events
Time frame: From date of randomization up to 30 days after the last study treatment
Subsequent treatment description
Time frame: From date of first subsequent treatment to the date of the end of study, assessed up to 8.5 years
Tumor response rate
Time frame: From the date of the first subsequent treatment to the date of the end of study, assessed up to 8.5 years
Quality of Life Questionnaire - Colorectal cancer associated with the Liver colorectal metastasis Module
Time frame: At baseline, 3 months then every 3 months for 3 years and every 6 months for the following 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maximiliano GELLI, Dr principal investigator
Gustave Roussy, Département Anesthésie Chirurgie et Interventionnel (DACI)
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Arterial catheter infusion chemotherapy and IV Chemotherapy (Regimen 1) in people with Colorectal Adenocarcinoma Metastatic in the Liver and Colorectal Cancer, run by UNICANCER.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michaël CHEVROT, PhD (+33171936161, m-chevrot@unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence-free survival (RFS) (time frame: From date of randomization to the date of occurrence of the first oncological event, assessed up to 8.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.