Colorectal CancerPhase 3SPARKLE-LNCT06794086
SBRT + PD-1 Monoclonal Antibody in Unresectable Colorectal Liver Metastases
A Phase 3 study testing Stereotactic body radiation therapy, PD-1 Monoclonal Antibody and Chemotherapy in people with Colorectal Cancer and Liver Metastases, run by Jun Huang at 1 site in China.
Trial summary
To explore the efficacy and safety of stereotactic body radiation therapy (SBRT) combined with PD-1 monoclonal antibody in the treatment of unresectable colorectal cancer liver metastasis through a prospective study, providing high-level evidence-based medical evidence for the use of SBRT combined with PD-1 inhibitors… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer, Liver Metastases
- What is being tested?
- Stereotactic body radiation therapy, PD-1 Monoclonal Antibody and Chemotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 10 Apr 2025to 20 Jan 2027
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent, voluntarily signed and dated by the subject, must be obtained in accordance with regulatory and institutional guidelines before any procedures related to the study protocol that are not part of routine care are performed.
- Patients with pMMR/MSS colorectal adenocarcinoma;
- Age 18-75 years;
- Patients with histologically or cytologically confirmed colorectal cancer liver metastasis, with or without extrahepatic oligometastatic lesions, who are deemed by the hepatobiliary surgeon within the multidisciplinary team (MDT) to be ineligible for upfront R0 resection of liver metastases (unresectability is defined as one or more of the following conditions: ① Involvement of both left and right branches of the portal vein at the first hepatic hilum; ② Involvement of ≥2 hepatic veins at the second hepatic hilum; ③ No indication for upfront R0 resection/ablation after MDT discussion);
- Liver metastases are measurable by imaging (based on RECIST 1.1 criteria), with a maximum diameter of ≤6 cm;
- Patients who have not previously received radiotherapy for liver metastases, or whose liver tissue near the planned irradiation site has not been previously irradiated, and who have at least 700 cc of liver volume outside the treatment area;
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- Previous hepatectomy, systemic chemotherapy, or local ablation therapy, or hepatic arterial infusion pump chemotherapy is allowed, with a washout period of 2 weeks;
- Child-Pugh score Class A ;
- ECOG performance status 0-1;
- Peripheral blood counts and liver and renal function within allowable ranges (tested within 15 days before the start of treatment);
- No history of other malignancies, not pregnant or breastfeeding, and effective contraception should be used during the study period and for 6 months after the last dose;
- Life expectancy of ≥6 months.
Who cannot join
- Active hepatitis, cirrhosis, or Child-Pugh score Class B or C;
- Extrahepatic metastases: bone or brain metastases, or ≥3 unresectable lung metastases (according to the 8th edition of the UICC);
- Unmeasurable liver metastases;
- History of severe drug allergies (including allergies to platinum agents, 5-FU, LV, and 5-HT3 receptor antagonists);
- Patients who have participated in or are currently participating in other clinical trials within the past 4 weeks;
- History of prior treatment with anti-PD-1, PD-L1, PD-L2, CTLA-4, or any other specific T-cell costimulatory or checkpoint pathway-targeted therapies;
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- Severe electrolyte abnormalities;
- Presence of gastrointestinal diseases, such as active gastric or duodenal ulcers, ulcerative colitis, or unresected tumors with active bleeding; or other conditions that may lead to gastrointestinal bleeding or perforation (Note: Gastrointestinal fistulas that have not healed after surgical treatment, such as rectovesical, rectourethral, or rectovaginal fistulas, are exclusionary unless a stoma has been created and there are no active symptoms);
- History of arterial thrombosis or deep vein thrombosis within 6 months; history of bleeding or evidence of bleeding tendency within 2 months;
- Pregnant or breastfeeding women, or women of childbearing potential with a positive pregnancy test before the first dose; or female participants unwilling to strictly practice contraception during the study, as well as their partners;
- Patients with active autoimmune deficiency diseases requiring systemic treatment within the past 2 years (i.e., use of immunomodulators, corticosteroids, or immunosuppressive drugs);
- Presence of other active malignancies (except for malignancies that have been treated with curative intent and have been disease-free for over 3 years, or in situ cancers that can be cured with adequate treatment);
- Presence of severe ECG abnormalities or active coronary artery disease within 12 months before study entry, severe/unstable angina, newly diagnosed angina or myocardial infarction, or New York Heart Association (NYHA) Class II or higher congestive heart failure;
- Patients with active infections (fever above 38°C due to infection);
- Patients with poorly controlled hypercalcemia, hypertension, or diabetes;
- Patients with severe pulmonary diseases (interstitial pneumonia, pulmonary fibrosis, severe emphysema, etc.);
- Patients with psychiatric disorders affecting clinical management or a history of central nervous system diseases;
- Patients with severe complications (intestinal obstruction, renal insufficiency, hepatic insufficiency, cerebrovascular disorders, etc.);
- Presence of any CTCAE Grade 2 or higher toxicity from prior treatments that has not resolved (except for anemia, alopecia, and skin pigmentation);
- Any unstable medical condition that may affect patient safety or compliance with the study;
- Patients deemed by the investigator to be unsuitable for participation in this clinical trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510065
Jun Hu, +86-020-38379764, zslyllb@mail.sysu.edu.cn
About this study
Official title: SBRT Combined With PD-1 Monoclonal Antibody in Unresectable Colorectal Liver Metastases: A Prospective, Multicenter, Single-arm, Phase II Clinical Study (SPARKLE-L)
To explore the efficacy and safety of stereotactic body radiation therapy (SBRT) combined with PD-1 monoclonal antibody in the treatment of unresectable colorectal cancer liver metastasis through a prospective study, providing high-level evidence-based medical evidence for the use of SBRT combined with PD-1 inhibitors in the treatment of unresectable colorectal cancer liver metastasis.
Read the detailed description
For patients with unresectable colorectal cancer liver metastasis, this study aims to explore whether the combination of stereotactic body radiation therapy (SBRT) and PD-1 monoclonal antibody can improve the objective response rate (ORR), achieve better long-term survival benefits, and enhance quality of life. Additionally, the study will investigate the efficacy and safety of SBRT combined with PD-1 monoclonal antibody for treating liver metastases, with the goal of providing high-level evidence-based medical evidence for the use of local hypofractionated radiotherapy combined with PD-1 monoclonal antibody in the treatment of unresectable colorectal cancer liver metastasis.
This is a prospective, open-label, multicenter, single-arm, Phase II study. Patients with colorectal cancer will be eligible for enrollment if the hepatobiliary surgery team within the multidisciplinary team (MDT) deems the liver metastases unresectable, and the radiation oncology team within the MDT considers the liver metastases suitable for stereotactic body radiation therapy (SBRT).
Enrolled patients will receive hypofractionated radiotherapy with a dose of 8-12 Gy in 5 fractions. Chemotherapy based on 5-FU combined with immunotherapy will be administered before and after radiotherapy. Eight weeks (±2 weeks) after the completion of radiotherapy, radiological assessment or multi-site liver biopsy will be performed. The MDT will then decide on the subsequent management: maintenance chemotherapy or watch-and-wait (W\&W) for patients achieving complete clinical response (cCR) or pathological complete response (pCR), or maintenance chemotherapy or discontinuation for patients who do not achieve cCR/pCR.
- Conditions
- Colorectal Cancer, Liver Metastases
- Being tested
- Stereotactic body radiation therapy, PD-1 Monoclonal Antibody, Chemotherapy
- Keywords
- Stereotactic body radiation therapy, PD-1 Monoclonal Antibody
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic body radiation therapyRadiation
Stereotactic body radiation therapy (SBRT) is a highly precise form of external beam radiation therapy used to treat tumors in various parts of the body. Enrolled patients will initiate SBRT treatment within 2 weeks after the first course of chemotherapy. Intensity-modulated radiation therapy (IMRT) will be used, with the gross tumor volume (GTV) receiving a dose of 8-12 Gy in 5 fractions, resulting in a total dose of 40-60 Gy. The biologically effective dose (BED) is equivalent to 72-132 Gy. The treatment will be administered from Monday to Friday.
PD-1 Monoclonal AntibodyDrug
Also called sintilimab
PD-1 monoclonal antibody is a type of immunotherapy drug designed to treat various cancers by targeting the programmed death receptor-1 (PD-1) pathway.The PD-1 monoclonal antibody used in this study is sintilimab at a dose of 200 mg, administered via intravenous infusion on Day 1. Participants will be considered eligible only if they have completed four or more cycles of PD-1 monoclonal antibody treatment both before and after SBRT.
ChemotherapyDrug
Also called fluorouracil
Chemotherapy regimens based on fluorouracil (5-FU), such as CAPOX with a 3-week cycle or mFOLFOX6/FOLFIRI/FOLFOXIRI with a 2-week cycle, may be combined with targeted therapy. During chemotherapy or chemoradiotherapy, optimal supportive care will be provided.
| Study group | Role | What they receive |
|---|---|---|
| SBRT plus PD-1 Monoclonal Antibody | Experimental | Enrolled patients will receive stereotactic body radiation therapy with a dose of 8-12 Gy in 5 fractions. Chemotherapy based on 5-FU combined with PD-1 monoclonal antibody immunotherapy will be administered before and after radiotherapy. Receives: Radiation: Stereotactic body radiation therapy; Drug: PD-1 Monoclonal Antibody; Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Objective Response Rate
Measured: 1 year
Secondary outcomes (8)
DCR
Disease Control Rate
Measured: 1 year
pCR
Pathological Complete Response
Measured: 1 year
1 year PFS
Local Progression-Free Survival of 1 Year
Measured: 1 year
1 year OS
Overall Survival of 1 Year
Measured: 1 year
2 years PFS
Local Progression-Free Survival of 2 Years
Measured: 2 years
2 years OS
Overall Survival of 2 Years
Measured: 2 years
R0 resection rate
The Rate of Negative margins under microscopy
Measured: 1 year
Acute toxicity reactions
Referring to the percentage of patients experiencing acute toxicities related to radiotherapy, chemotherapy, and immunotherapy
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start10 Apr 2025
- Primary completion20 Jun 2026 (estimated)
- Study completion20 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- SBRT plus PD-1 Monoclonal Antibody
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jun Huang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jun Huang, Sixth Affiliated Hospital, Sun Yat-sen University
- Investigators
- Jun Huang, PhD., Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06794086
- Sponsor's protocol ID
- E2024366
- Acronym
- SPARKLE-L
- Status last verified
- Jun 2026
- First submitted
- 20 Jan 2025
- Last updated
- 30 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SBRT Combined With PD-1 Monoclonal Antibody in Unresectable Colorectal Liver Metastases: A Prospective, Multicenter, Single-arm, Phase II Clinical Study (SPARKLE-L)
- ClinicalTrials.gov ID
- NCT06794086
- Acronym / sponsor ID
- SPARKLE-L / E2024366
- Conditions
- Colorectal Cancer, Liver Metastases
- Keywords
- Stereotactic body radiation therapy, PD-1 Monoclonal Antibody
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Jun HuangUniversity, hospital or other
- Study start
- 10 Apr 2025 (actual)
- Primary completion
- 20 Jun 2026 (estimated)
- Study completion
- 20 Jan 2027 (estimated)
- First posted
- 27 Jan 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.
To explore the efficacy and safety of stereotactic body radiation therapy (SBRT) combined with PD-1 monoclonal antibody in the treatment of unresectable colorectal cancer liver metastasis through a prospective study, providing high-level evidence-based medical evidence for the use of SBRT combined with PD-1 inhibitors in the treatment of unresectable colorectal cancer liver metastasis.
Detailed description
For patients with unresectable colorectal cancer liver metastasis, this study aims to explore whether the combination of stereotactic body radiation therapy (SBRT) and PD-1 monoclonal antibody can improve the objective response rate (ORR), achieve better long-term survival benefits, and enhance quality of life. Additionally, the study will investigate the efficacy and safety of SBRT combined with PD-1 monoclonal antibody for treating liver metastases, with the goal of providing high-level evidence-based medical evidence for the use of local hypofractionated radiotherapy combined with PD-1 monoclonal antibody in the treatment of unresectable colorectal cancer liver metastasis.
This is a prospective, open-label, multicenter, single-arm, Phase II study. Patients with colorectal cancer will be eligible for enrollment if the hepatobiliary surgery team within the multidisciplinary team (MDT) deems the liver metastases unresectable, and the radiation oncology team within the MDT considers the liver metastases suitable for stereotactic body radiation therapy (SBRT).
Enrolled patients will receive hypofractionated radiotherapy with a dose of 8-12 Gy in 5 fractions. Chemotherapy based on 5-FU combined with immunotherapy will be administered before and after radiotherapy. Eight weeks (±2 weeks) after the completion of radiotherapy, radiological assessment or multi-site liver biopsy will be performed. The MDT will then decide on the subsequent management: maintenance chemotherapy or watch-and-wait (W\&W) for patients achieving complete clinical response (cCR) or pathological complete response (pCR), or maintenance chemotherapy or discontinuation for patients who do not achieve cCR/pCR.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- SBRT plus PD-1 Monoclonal Antibody
| Arm | Type | Receives |
|---|---|---|
| SBRT plus PD-1 Monoclonal Antibody | Experimental | Radiation: Stereotactic body radiation therapy, Drug: PD-1 Monoclonal Antibody, Drug: ChemotherapyEnrolled patients will receive stereotactic body radiation therapy with a dose of 8-12 Gy in 5 fractions. Chemotherapy based on 5-FU combined with PD-1 monoclonal antibody immunotherapy will be administered before and after radiotherapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Written informed consent, voluntarily signed and dated by the subject, must be obtained in accordance with regulatory and institutional guidelines before any procedures related to the study protocol that are not part of routine care are performed.
- Patients with pMMR/MSS colorectal adenocarcinoma;
- Age 18-75 years;
- Patients with histologically or cytologically confirmed colorectal cancer liver metastasis, with or without extrahepatic oligometastatic lesions, who are deemed by the hepatobiliary surgeon within the multidisciplinary team (MDT) to be ineligible for upfront R0 resection of liver metastases (unresectability is defined as one or more of the following conditions: ① Involvement of both left and right branches of the portal vein at the first hepatic hilum; ② Involvement of ≥2 hepatic veins at the second hepatic hilum; ③ No indication for upfront R0 resection/ablation after MDT discussion);
- Liver metastases are measurable by imaging (based on RECIST 1.1 criteria), with a maximum diameter of ≤6 cm;
Key exclusion criteria (21 listed)
- Active hepatitis, cirrhosis, or Child-Pugh score Class B or C;
- Extrahepatic metastases: bone or brain metastases, or ≥3 unresectable lung metastases (according to the 8th edition of the UICC);
- Unmeasurable liver metastases;
- History of severe drug allergies (including allergies to platinum agents, 5-FU, LV, and 5-HT3 receptor antagonists);
- Patients who have participated in or are currently participating in other clinical trials within the past 4 weeks;
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 |
|---|---|---|
| Stereotactic body radiation therapyStereotactic body radiation therapy (SBRT) is a highly precise form of external beam radiation therapy used to treat tumors in various parts of the body. Enrolled patients will initiate SBRT treatment within 2 weeks after the first course of chemotherapy. Intensity-modulated radiation therapy (IMRT) will be used, with the gross tumor volume (GTV) receiving a dose of 8-12 Gy in 5 fractions, resulting in a total dose of 40-60 Gy. The biologically effective dose (BED) is equivalent to 72-132 Gy. The treatment will be administered from Monday to Friday. | Radiation | SBRT plus PD-1 Monoclonal Antibody |
| PD-1 Monoclonal AntibodyAlso: sintilimabPD-1 monoclonal antibody is a type of immunotherapy drug designed to treat various cancers by targeting the programmed death receptor-1 (PD-1) pathway.The PD-1 monoclonal antibody used in this study is sintilimab at a dose of 200 mg, administered via intravenous infusion on Day 1. Participants will be considered eligible only if they have completed four or more cycles of PD-1 monoclonal antibody treatment both before and after SBRT. | Drug | SBRT plus PD-1 Monoclonal Antibody |
| ChemotherapyAlso: fluorouracilChemotherapy regimens based on fluorouracil (5-FU), such as CAPOX with a 3-week cycle or mFOLFOX6/FOLFIRI/FOLFOXIRI with a 2-week cycle, may be combined with targeted therapy. During chemotherapy or chemoradiotherapy, optimal supportive care will be provided. | Drug | SBRT plus PD-1 Monoclonal Antibody |
Primary outcome
ORR
Time frame: 1 year
Objective Response Rate
8 secondary outcomes
DCR
Time frame: 1 year
pCR
Time frame: 1 year
1 year PFS
Time frame: 1 year
1 year OS
Time frame: 1 year
2 years PFS
Time frame: 2 years
2 years OS
Time frame: 2 years
R0 resection rate
Time frame: 1 year
Acute toxicity reactions
Time frame: 1 year
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 30 Jun 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.
Jun Huang, PhD. principal investigator
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Stereotactic body radiation therapy, PD-1 Monoclonal Antibody and Chemotherapy in people with Colorectal Cancer and Liver Metastases, run by Jun Huang 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 12 inclusion and 21 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: looking for participants now, as of the sponsor's last update on 30 Jun 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.
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 Jun Huang, PhD. (13926451242, huangj97@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: 1 year). 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 30 Jun 2026.