Liver Metastasis Colon CancerNCT06199232
Targeted Treatment Plus Tislelizumab and HAIC for Advanced CRCLM Failed From Standard Systemic Treatment
A study testing HAIC+targeted therapy+PD-1 inhibitor in people with Liver Metastasis Colon Cancer and ctDNA Genotype, run by Peking University at 1 site in China.
Trial summary
Hepatic arterial infuison chemothearpy (HAIC), targeted therapy, and programmed death-1 (PD-1) inhibitors have been demonstrated to be effective for colorectal cancer liver metastasis (CRCLM). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Liver Metastasis Colon Cancer, ctDNA Genotype, MSS
- What is being tested?
- HAIC+targeted therapy+PD-1 inhibitor
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteChina
- Study dates
- 23 Jan 2024to 10 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-80 years old.
- Colorectal cancer confirmed by histopatology.
- The metastasis is mainly located in liver.
- Unresectable liver metastasis is confirmed by CT/MRI scan and multidisciplinary.
- Failed from standard first- and second-line systemic treatment.
- At least one measurable lesion according to modified Response Evaluation Criteria in Solid Tumors guidelines (mRECIST).
Show all 18Show fewer
- Eastern Cooperative Oncology Group (ECOG) performance status <2.
- Child-Pugh A or B (≤ 7).
- Expectant survival time ≥ 3 months.
- Adequate organ function as follows:
- Hemoglobin ≥ 90 g/L;
- Absolute neutrophil count ≥ 1.5×10^9/L;
- Blood platelet count ≥ 775×10^9/L;
- Alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤ 5 times of upper limit of normal (ULN);
- Total bilirubin ≤ 2 times of ULN;
- Serum creatinine ≤ 1.5 times of ULN;
- Albumin ≥ 30 g/L.
- Patients sign informed consent.
Who cannot join
- Extensive extrahepatic metastasis (>25% of tumor burden in liver).
- HER2 (3+) or HER2 amplification.
- MSI-H or dMMR.
- Allergic to contrast media.
- Pregnant or lactational.
- Allergic to oxaliplatin or cetuximab.
Show all 20Show fewer
- Coinstantaneous a lot of malignant hydrothorax or ascites.
- History of organ transplantation (including bone marrow auto-transplantation and peripheral stem cell transplantation).
- Coinstantaneous infection and need anti-infection therapy.
- Coinstantaneous peripheral nervous system disorder.
- History of obvious mental disorder and central nervous system disorder.
- Concomitant malignancy within 5 years, except for non-melanoma skin cancer and carcinoma in situ of cervix.
- Without legal capacity.
- Impact the study because of medical or ethical reasons.
- Clinically severe gastrointestinal bleeding within 6 months of the start of treatment or any life-threatening bleeding events within 3 months of the start of treatment.
- Uncorrectable coagulation disorder.
- Obvious abnormal in ECG or obvious clinical symptoms of heart disease, like congestive heart failure, coronary heart disease with obvious clinical symptoms, unmanageable arrhythmia and hypertension.
- History of myocardial infarction within 12 months, or Grade III/IV of heart function.
- Severe liver disease (like cirrhosis), renal disease, respiratory disease, unmanageable diabetes or other kinds of systematic disease.
- Any other subjects that the investigator considers ineligible.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Univerisity Cancer Hospital
Beijing, Beijing Municipality, 100142
About this study
Official title: Targeted Treatment Based on ctDNA Genotyping Combined With Tislelizumab and HAIC as Salvage Treatment for Advanced Colorectal Cancer Liver Metastasis Failed From Standard Systemic Treatment (SALVLIV Trial)
Hepatic arterial infuison chemothearpy (HAIC), targeted therapy, and programmed death-1 (PD-1) inhibitors have been demonstrated to be effective for colorectal cancer liver metastasis (CRCLM). Thus, the investigators will conduct a prospective trial to explore the efficacy and safety of targeted treatment based on genotyping or ctDNA genotyping combined with tislelizumab and HAIC as salvage treatment for advanced CRCLM failed from standard systemic treatment, aiming to provide individualized optimized regimen for microsatellite stable (MSS) CRCLM in salvage treatment.
Read the detailed description
Although surgery has been demonstrated to improve the prognosis of patients with colorectal cancer liver metastasis (CRCLM), only 20% of patients with CRCLM is candidate for surger. Irinotecan-/oxaliplatin-based doublet/triplet chemotherapy regimen combined with targeted therapy (anti vascular endothelial growth factor [VEFG] or anti epidermal growth factor receptor [EGFR]) based on the genotype are recommended as standard first- and second-line treatment for unresectabel metastatic colorectal cancer (mCRC) by NCCN guideline. RAS and BRAF are the important signal members in the EGFR signal pathway, and the mutation of them could induce the persistent activation of the downstream of the MAPK pathway, leading to the differentiation, proliferation, and growth change of the tumor cell. The status of RAS and BRAF V600E mutation will affect the efficacy of anti-EGFR therapy, but not anti-VEGF therapy.
Regorafenib, fruquintinb, and TAS-102 have been recommended as third-line treatment for mCRC, while the survivl benefits from these agents are limited, with the median progression-free survival (PFS) and median OS of 1.9-3.7 months and 6.4-9.3 months, respectively.
The efficacy and safety of hepatic arterial infusion chemotherapy (HAIC) for CRCLM have been demonstrated by multiple trials and recommended by many guidelines worldwide. Fruquintinib, a small molecular tyrosine kinase inhibitor targeting at VEGF 1-3, has been demonstrated to change the tumor microenvironment and enhance the anti-tumor effect of programmed death-1 (PD-1) inhibitor in microsatellite stable (MSS) CRC. Anti-EGFR rechallenge (cetuximab rechallenge) was effective in patients with CRC who interrupted the anti-EGFR therapy while responsed to anti-EGFR therapy in the first-line treatment. In 2021, a phase II trial, which explore the efficacy and safety of cetuximab rechallenge combined with Avelumab for pretreated RAS wide type (WT) mCRC. Our retrospective study (unpublished) showed HAIC combined with fruquintinib and tislelizumab presented greater efficacy for MSS CRCLM.
Thus, the investigators will conduct a prospective trial to explore the efficacy and safety of targeted treatment based on genotyping or ctDNA genotyping combined with tislelizumab and HAIC as salvage treatment for advanced CRCLM failed from standard systemic treatment, aiming to provide individualized optimized regimen for MSS CRCLM in salvage treatment.
- Being tested
- HAIC+targeted therapy+PD-1 inhibitor
- Keywords
- hepatic arterial infusion chemotherapy, targeted therapy, tislelizumab, ctDNA genotype, MSS CRCLM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HAIC+targeted therapy+PD-1 inhibitorDrug
Also called HAIC+Fruquintinib/Cetuximab+Tislelizumab
HAIC regimen: doublet or triplet regimen based on the response and adverse events occurred in the previous standard treatment (depended on the decision of researchers)-oxaliplatin (85 mg/m2, split into d1 and d2, 0-2h,) and 5-fluorouracial (2g/m2, split into d1 and d2, 2-24h)/ oxaliplatin (65 mg/m2, 0-2h, d1), irinotecan (100 mg/m2, 0-2h, d2), and 5-fluorouracial (2g/m2, split in d1 and d2, 2-24h), repeated every 4 weeks; drug-eluting TACE will be performed at 3rd-4th cycles if the lesions in liver is abundant with blood supply.
Tislelizumab (a PD-1 inhibitor): 200 mg, intravenous drip for 30-60 minutes before 24h of HAIC, q4w.
Cetuximab (Group A, KRAS/NRAK/BRAF/EGFR wide type and interrupt cetuximab more than 3 months): 500 mg/m2, intravenous drip before HAIC, q4w.
Fruquintinib (Group B, KRAS/NRAS/BRAF/EGFR mutation type and wide type but treated with cetuximab in last 3 months): 3 mg/d, d3-23, then suspend for 1w.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | HAIC combined with targeted therapy and PD-1 inhibitor Receives: Drug: HAIC+targeted therapy+PD-1 inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS rate at 6 months
Proportion of patients with 6- month progression-free survival after treatment begining in all patients.
Measured: From the date of treatment begining to the date of 6 months after the treatment begining.
Secondary outcomes (6)
PFS
The time from treatment initiation to the first documented disease progression or death due to any cause, whichever occurs firstly
Measured: From date of treatment beginning until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
OS
The time from treatment initiation to death due to any cause
Measured: From date of treatment beginning until the date of death from any cause, assessed up to 100 months
intrahepatic PFS
The time from treatment initiation to the first documented disease progression in liver or death due to any cause, whichever occurs firstly
Measured: From date of treatment beginning until the date of first documented progression in liver or date of death from any cause, whichever came first, assessed up to 100 months
ORR
The proportion of participants in the analysis population who have complete response (CR) or partial response (PR) determined by investigators using mRECIST criteria at any time during the study.
Measured: Evaluation of tumor burden based on mRECIST criteria through study completion, an average of once per 3 months.
DCR
The proportion of participants in the analysis population who have complete response (CR), partial response (PR), or stable disease (SD) determined by investigators using mRECIST criteria at any time during the study.
Measured: Evaluation of tumor burden based on mRECIST criteria through study completion, an average of once per 3 months.
Number of patients with treatment-related adverse events
Number of patients with AE, treatment-related AE (TRAE), serious adverse event (SAE) assessed by CTCAE v5.0.
Measured: Through study completion, an average of once per 1 month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start23 Jan 2024
- Primary completion10 Jul 2026
- Study completion10 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Liver Metastasis Colon CancerStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiaodong Wang, M.D., Study director, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06199232
- Sponsor's protocol ID
- SALVLIVE
- Status last verified
- Jan 2026
- First submitted
- 24 Dec 2023
- Last updated
- 28 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kanas GP, Taylor A, Primrose JN, Langeberg WJ, Kelsh MA, Mowat FS, Alexander DD, Choti MA, Poston G. Survival after liver resection in metastatic colorectal cancer: review and meta-analysis of prognostic factors. Clin Epidemiol. 2012;4:283-301. doi: 10.2147/CLEP.S34285. Epub 2012 Nov 7.
PubMed 23152705Hackl C, Neumann P, Gerken M, Loss M, Klinkhammer-Schalke M, Schlitt HJ. Treatment of colorectal liver metastases in Germany: a ten-year population-based analysis of 5772 cases of primary colorectal adenocarcinoma. BMC Cancer. 2014 Nov 4;14:810. doi: 10.1186/1471-2407-14-810.
PubMed 25369977Cho M, Gong J, Fakih M. The state of regional therapy in the management of metastatic colorectal cancer to the liver. Expert Rev Anticancer Ther. 2016;16(2):229-45. doi: 10.1586/14737140.2016.1129277. Epub 2016 Jan 13.
PubMed 26652741Wang Y, Wei B, Gao J, Cai X, Xu L, Zhong H, Wang B, Sun Y, Guo W, Xu Q, Gu Y. Combination of Fruquintinib and Anti-PD-1 for the Treatment of Colorectal Cancer. J Immunol. 2020 Nov 15;205(10):2905-2915. doi: 10.4049/jimmunol.2000463. Epub 2020 Oct 7.
PubMed 33028620Li Q, Cheng X, Zhou C, Tang Y, Li F, Zhang B, Huang T, Wang J, Tu S. Fruquintinib Enhances the Antitumor Immune Responses of Anti-Programmed Death Receptor-1 in Colorectal Cancer. Front Oncol. 2022 Mar 17;12:841977. doi: 10.3389/fonc.2022.841977. eCollection 2022.
PubMed 35371995Grothey A, Van Cutsem E, Sobrero A, Siena S, Falcone A, Ychou M, Humblet Y, Bouche O, Mineur L, Barone C, Adenis A, Tabernero J, Yoshino T, Lenz HJ, Goldberg RM, Sargent DJ, Cihon F, Cupit L, Wagner A, Laurent D; CORRECT Study Group. Regorafenib monotherapy for previously treated metastatic colorectal cancer (CORRECT): an international, multicentre, randomised, placebo-controlled, phase 3 trial. Lancet. 2013 Jan 26;381(9863):303-12. doi: 10.1016/S0140-6736(12)61900-X. Epub 2012 Nov 22.
PubMed 23177514Li J, Qin S, Xu R, Yau TC, Ma B, Pan H, Xu J, Bai Y, Chi Y, Wang L, Yeh KH, Bi F, Cheng Y, Le AT, Lin JK, Liu T, Ma D, Kappeler C, Kalmus J, Kim TW; CONCUR Investigators. Regorafenib plus best supportive care versus placebo plus best supportive care in Asian patients with previously treated metastatic colorectal cancer (CONCUR): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2015 Jun;16(6):619-29. doi: 10.1016/S1470-2045(15)70156-7. Epub 2015 May 13.
PubMed 25981818Li J, Qin S, Xu RH, Shen L, Xu J, Bai Y, Yang L, Deng Y, Chen ZD, Zhong H, Pan H, Guo W, Shu Y, Yuan Y, Zhou J, Xu N, Liu T, Ma D, Wu C, Cheng Y, Chen D, Li W, Sun S, Yu Z, Cao P, Chen H, Wang J, Wang S, Wang H, Fan S, Hua Y, Su W. Effect of Fruquintinib vs Placebo on Overall Survival in Patients With Previously Treated Metastatic Colorectal Cancer: The FRESCO Randomized Clinical Trial. JAMA. 2018 Jun 26;319(24):2486-2496. doi: 10.1001/jama.2018.7855.
PubMed 29946728Mayer RJ, Van Cutsem E, Falcone A, Yoshino T, Garcia-Carbonero R, Mizunuma N, Yamazaki K, Shimada Y, Tabernero J, Komatsu Y, Sobrero A, Boucher E, Peeters M, Tran B, Lenz HJ, Zaniboni A, Hochster H, Cleary JM, Prenen H, Benedetti F, Mizuguchi H, Makris L, Ito M, Ohtsu A; RECOURSE Study Group. Randomized trial of TAS-102 for refractory metastatic colorectal cancer. N Engl J Med. 2015 May 14;372(20):1909-19. doi: 10.1056/NEJMoa1414325.
PubMed 25970050
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Treatment Based on ctDNA Genotyping Combined With Tislelizumab and HAIC as Salvage Treatment for Advanced Colorectal Cancer Liver Metastasis Failed From Standard Systemic Treatment (SALVLIV Trial)
- ClinicalTrials.gov ID
- NCT06199232
- Acronym / sponsor ID
- SALVLIVE
- Keywords
- hepatic arterial infusion chemotherapy, targeted therapy, tislelizumab, ctDNA genotype, MSS CRCLM
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 23 Jan 2024 (actual)
- Primary completion
- 10 Jul 2026 (actual)
- Study completion
- 10 Jul 2026 (actual)
- First posted
- 10 Jan 2024 (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.
Hepatic arterial infuison chemothearpy (HAIC), targeted therapy, and programmed death-1 (PD-1) inhibitors have been demonstrated to be effective for colorectal cancer liver metastasis (CRCLM). Thus, the investigators will conduct a prospective trial to explore the efficacy and safety of targeted treatment based on genotyping or ctDNA genotyping combined with tislelizumab and HAIC as salvage treatment for advanced CRCLM failed from standard systemic treatment, aiming to provide individualized optimized regimen for microsatellite stable (MSS) CRCLM in salvage treatment.
Detailed description
Although surgery has been demonstrated to improve the prognosis of patients with colorectal cancer liver metastasis (CRCLM), only 20% of patients with CRCLM is candidate for surger. Irinotecan-/oxaliplatin-based doublet/triplet chemotherapy regimen combined with targeted therapy (anti vascular endothelial growth factor [VEFG] or anti epidermal growth factor receptor [EGFR]) based on the genotype are recommended as standard first- and second-line treatment for unresectabel metastatic colorectal cancer (mCRC) by NCCN guideline. RAS and BRAF are the important signal members in the EGFR signal pathway, and the mutation of them could induce the persistent activation of the downstream of the MAPK pathway, leading to the differentiation, proliferation, and growth change of the tumor cell. The status of RAS and BRAF V600E mutation will affect the efficacy of anti-EGFR therapy, but not anti-VEGF therapy.
Regorafenib, fruquintinb, and TAS-102 have been recommended as third-line treatment for mCRC, while the survivl benefits from these agents are limited, with the median progression-free survival (PFS) and median OS of 1.9-3.7 months and 6.4-9.3 months, respectively.
The efficacy and safety of hepatic arterial infusion chemotherapy (HAIC) for CRCLM have been demonstrated by multiple trials and recommended by many guidelines worldwide. Fruquintinib, a small molecular tyrosine kinase inhibitor targeting at VEGF 1-3, has been demonstrated to change the tumor microenvironment and enhance the anti-tumor effect of programmed death-1 (PD-1) inhibitor in microsatellite stable (MSS) CRC. Anti-EGFR rechallenge (cetuximab rechallenge) was effective in patients with CRC who interrupted the anti-EGFR therapy while responsed to anti-EGFR therapy in the first-line treatment. In 2021, a phase II trial, which explore the efficacy and safety of cetuximab rechallenge combined with Avelumab for pretreated RAS wide type (WT) mCRC. Our retrospective study (unpublished) showed HAIC combined with fruquintinib and tislelizumab presented greater efficacy for MSS CRCLM.
Thus, the investigators will conduct a prospective trial to explore the efficacy and safety of targeted treatment based on genotyping or ctDNA genotyping combined with tislelizumab and HAIC as salvage treatment for advanced CRCLM failed from standard systemic treatment, aiming to provide individualized optimized regimen for MSS CRCLM in salvage treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Drug: HAIC+targeted therapy+PD-1 inhibitorHAIC combined with targeted therapy and PD-1 inhibitor |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 18-80 years old.
- Colorectal cancer confirmed by histopatology.
- The metastasis is mainly located in liver.
- Unresectable liver metastasis is confirmed by CT/MRI scan and multidisciplinary.
- Failed from standard first- and second-line systemic treatment.
Key exclusion criteria (20 listed)
- Extensive extrahepatic metastasis (>25% of tumor burden in liver).
- HER2 (3+) or HER2 amplification.
- MSI-H or dMMR.
- Allergic to contrast media.
- Pregnant or lactational.
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 |
|---|---|---|
| HAIC+targeted therapy+PD-1 inhibitorAlso: HAIC+Fruquintinib/Cetuximab+TislelizumabHAIC regimen: doublet or triplet regimen based on the response and adverse events occurred in the previous standard treatment (depended on the decision of researchers)-oxaliplatin (85 mg/m2, split into d1 and d2, 0-2h,) and 5-fluorouracial (2g/m2, split into d1 and d2, 2-24h)/ oxaliplatin (65 mg/m2, 0-2h, d1), irinotecan (100 mg/m2, 0-2h, d2), and 5-fluorouracial (2g/m2, split in d1 and d2, 2-24h), repeated every 4 weeks; drug-eluting TACE will be performed at 3rd-4th cycles if the lesions in liver is abundant with blood supply. Tislelizumab (a PD-1 inhibitor): 200 mg, intravenous drip for 30-60 minutes before 24h of HAIC, q4w. Cetuximab (Group A, KRAS/NRAK/BRAF/EGFR wide type and interrupt cetuximab more than 3 months): 500 mg/m2, intravenous drip before HAIC, q4w. Fruquintinib (Group B, KRAS/NRAS/BRAF/EGFR mutation type and wide type but treated with cetuximab in last 3 months): 3 mg/d, d3-23, then suspend for 1w. | Drug | Treatment Arm |
Primary outcome
PFS rate at 6 months
Time frame: From the date of treatment begining to the date of 6 months after the treatment begining.
Proportion of patients with 6- month progression-free survival after treatment begining in all patients.
6 secondary outcomes
PFS
Time frame: From date of treatment beginning until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
OS
Time frame: From date of treatment beginning until the date of death from any cause, assessed up to 100 months
intrahepatic PFS
Time frame: From date of treatment beginning until the date of first documented progression in liver or date of death from any cause, whichever came first, assessed up to 100 months
ORR
Time frame: Evaluation of tumor burden based on mRECIST criteria through study completion, an average of once per 3 months.
DCR
Time frame: Evaluation of tumor burden based on mRECIST criteria through study completion, an average of once per 3 months.
Number of patients with treatment-related adverse events
Time frame: Through study completion, an average of once per 1 month.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Background: PubMed 23152705Kanas GP, Taylor A, Primrose JN, Langeberg WJ, Kelsh MA, Mowat FS, Alexander DD, Choti MA, Poston G. Survival after liver resection in metastatic colorectal cancer: review and meta-analysis of prognostic factors. Clin Epidemiol. 2012;4:283-301. doi: 10.2147/CLEP.S34285. Epub 2012 Nov 7.
- Background: PubMed 25369977Hackl C, Neumann P, Gerken M, Loss M, Klinkhammer-Schalke M, Schlitt HJ. Treatment of colorectal liver metastases in Germany: a ten-year population-based analysis of 5772 cases of primary colorectal adenocarcinoma. BMC Cancer. 2014 Nov 4;14:810. doi: 10.1186/1471-2407-14-810.
- Background: PubMed 26652741Cho M, Gong J, Fakih M. The state of regional therapy in the management of metastatic colorectal cancer to the liver. Expert Rev Anticancer Ther. 2016;16(2):229-45. doi: 10.1586/14737140.2016.1129277. Epub 2016 Jan 13.
- Background: PubMed 33028620Wang Y, Wei B, Gao J, Cai X, Xu L, Zhong H, Wang B, Sun Y, Guo W, Xu Q, Gu Y. Combination of Fruquintinib and Anti-PD-1 for the Treatment of Colorectal Cancer. J Immunol. 2020 Nov 15;205(10):2905-2915. doi: 10.4049/jimmunol.2000463. Epub 2020 Oct 7.
- Background: PubMed 35371995Li Q, Cheng X, Zhou C, Tang Y, Li F, Zhang B, Huang T, Wang J, Tu S. Fruquintinib Enhances the Antitumor Immune Responses of Anti-Programmed Death Receptor-1 in Colorectal Cancer. Front Oncol. 2022 Mar 17;12:841977. doi: 10.3389/fonc.2022.841977. eCollection 2022.
- Results publication: PubMed 23177514Grothey A, Van Cutsem E, Sobrero A, Siena S, Falcone A, Ychou M, Humblet Y, Bouche O, Mineur L, Barone C, Adenis A, Tabernero J, Yoshino T, Lenz HJ, Goldberg RM, Sargent DJ, Cihon F, Cupit L, Wagner A, Laurent D; CORRECT Study Group. Regorafenib monotherapy for previously treated metastatic colorectal cancer (CORRECT): an international, multicentre, randomised, placebo-controlled, phase 3 trial. Lancet. 2013 Jan 26;381(9863):303-12. doi: 10.1016/S0140-6736(12)61900-X. Epub 2012 Nov 22.
- Results publication: PubMed 25981818Li J, Qin S, Xu R, Yau TC, Ma B, Pan H, Xu J, Bai Y, Chi Y, Wang L, Yeh KH, Bi F, Cheng Y, Le AT, Lin JK, Liu T, Ma D, Kappeler C, Kalmus J, Kim TW; CONCUR Investigators. Regorafenib plus best supportive care versus placebo plus best supportive care in Asian patients with previously treated metastatic colorectal cancer (CONCUR): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2015 Jun;16(6):619-29. doi: 10.1016/S1470-2045(15)70156-7. Epub 2015 May 13.
- Results publication: PubMed 29946728Li J, Qin S, Xu RH, Shen L, Xu J, Bai Y, Yang L, Deng Y, Chen ZD, Zhong H, Pan H, Guo W, Shu Y, Yuan Y, Zhou J, Xu N, Liu T, Ma D, Wu C, Cheng Y, Chen D, Li W, Sun S, Yu Z, Cao P, Chen H, Wang J, Wang S, Wang H, Fan S, Hua Y, Su W. Effect of Fruquintinib vs Placebo on Overall Survival in Patients With Previously Treated Metastatic Colorectal Cancer: The FRESCO Randomized Clinical Trial. JAMA. 2018 Jun 26;319(24):2486-2496. doi: 10.1001/jama.2018.7855.
- Results publication: PubMed 25970050Mayer RJ, Van Cutsem E, Falcone A, Yoshino T, Garcia-Carbonero R, Mizunuma N, Yamazaki K, Shimada Y, Tabernero J, Komatsu Y, Sobrero A, Boucher E, Peeters M, Tran B, Lenz HJ, Zaniboni A, Hochster H, Cleary JM, Prenen H, Benedetti F, Mizuguchi H, Makris L, Ito M, Ohtsu A; RECOURSE Study Group. Randomized trial of TAS-102 for refractory metastatic colorectal cancer. N Engl J Med. 2015 May 14;372(20):1909-19. doi: 10.1056/NEJMoa1414325.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Xiaodong Wang, M.D. study director
Peking University Cancer Hospital & Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HAIC+targeted therapy+PD-1 inhibitor in people with Liver Metastasis Colon Cancer and ctDNA Genotype, run by Peking University at 1 site in China.
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 18 inclusion and 20 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: finished, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS rate at 6 months (time frame: From the date of treatment begining to the date of 6 months after the treatment begining.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06199232, which also lists 9 linked publications.
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 28 Jul 2026.