Unresectable Locally Recurrent Rectal CancerPhase 2NCT06767007
SBRT + PD-1 Antibody in Unresectable Locally Recurrent Rectal Cancer（SPARKLE）
A Phase 2 study testing Stereotactic Body Radiation Therapy (SBRT), PD1 and Chemotherapy in people with Unresectable Locally Recurrent Rectal Cancer, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
Trial summary
This is a prospective study to delve into the therapeutic benefits of combining stereotactic body radiation therapy (SBRT) with PD-1 monoclonal antibody treatment for patients with unresectable locally recurrent rectal cancer (ULRRC). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Unresectable Locally Recurrent Rectal Cancer
- What is being tested?
- Stereotactic Body Radiation Therapy (SBRT), PD1 and Chemotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteChina
- Study dates
- 6 Jan 2025to 30 Nov 2027
- Phase
- Phase 2
- 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
- Before implementing procedures related to the research protocol rather than routine care, informed consent forms with the subject's voluntary signature and dated must be obtained in accordance with regulations and institutional guidelines;
- Patients with pMMR/MSS colorectal cancer;
- Age between 18 and 75 years;
- Tumor recurrence confirmed by histology, cytology, or imaging, and the multidisciplinary team (MDT) including surgeons assesses that the recurrent lesion cannot achieve a one-stage R0 resection (unresectable is defined as: 1. Pelvic MRI showing sacral infiltration at or above S2, 2. And/or lateral pelvic wall invasion, 3. And/or obturator vascular nerve infiltration, 4. After MDT discussion, there are no indications for a one-stage R0 resection, 5. The patient refuses total pelvic exenteration or debulking surgery);
- Locally recurrent rectal adenocarcinoma without clear distant metastasis at diagnosis/MDT team assesses oligometastases as resectable/controllable (UICC 8th edition);
- No prior radiotherapy, or a gap of more than 6 months between the completion of initial radiotherapy and the start of retreatment, with a previous radiotherapy dose of less than 50.4Gy, and no late toxicity in the small bowel or bladder;
Show all 16Show fewer
- ECOG performance status 0-1;
- Peripheral blood counts and liver and kidney functions within the following allowed ranges (tested within 15 days before treatment start):
- White blood cells (WBC) ≥ 3.0×10^9/L or Absolute Neutrophil Count (ANC) ≥ 1.5×10^9/L;
- Hemoglobin (HGB) ≥ 80 g/L;
- Platelets (PLT) ≥ 100×10^9/L;
- Liver transaminases (AST/ALT) < 3.0 times the upper limit of the normal range;
- Total bilirubin (TBIL) < 1.5 times the upper limit of the normal range;
- Creatinine (CREAT) < 1.5 times the upper limit of the normal range;
- No history of other malignancies, not pregnant or breastfeeding, and should use effective contraception during the study period and for 6 months after the last administration;
- Expected survival ≥ 12 months.
Who cannot join
- Patients with a history of severe drug allergies (including allergies to platinum-based agents, 5-FU, LV, and 5-HT3 receptor antagonists);
- Patients who have participated in or are currently participating in other clinical trials within 4 weeks of enrollment;
- History of receiving anti-PD-1, PD-L1, PD-L2, CTLA-4, or any other specific T-cell co-stimulation or checkpoint pathway targeted therapies;
- Severe electrolyte abnormalities;
- Presence of gastrointestinal diseases, such as active ulcers of the stomach or duodenum, ulcerative colitis, or unresected tumors with active bleeding; or other conditions that may lead to gastrointestinal bleeding or perforation; or gastrointestinal perforations that have not healed after surgical treatment;
- History of arterial thrombosis or deep vein thrombosis within 6 months; history of bleeding or evidence of bleeding tendency within 2 months;
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- Pregnant or breastfeeding women or women who may become pregnant with a positive pregnancy test before the first dose; or female participants who are unwilling to strictly use contraception during the study period and their partners;
- Brain metastases with a diameter greater than 3cm or a total volume greater than 30cc;
- Clinical or radiological evidence of spinal cord compression, or tumors within 3 millimeters of the spinal cord on MRI;
- History or concurrent presence of other active malignant tumors (except for malignant tumors that have been treated curatively and have not recurred for more than 3 years or carcinoma in situ that can be cured with adequate treatment);
- Combined with severe electrocardiogram abnormalities or active coronary artery disease within 12 months before participating in the study, severe/unstable angina or newly diagnosed angina or myocardial infarction, New York Heart Association (NYHA) Class II or higher congestive heart failure;
- Patients with active infections (infections causing fever above 38°C);
- Patients with poorly controlled hypercalcemia, hypertension, diabetes;
- Patients with severe pulmonary diseases (interstitial pneumonia, pulmonary fibrosis, severe emphysema, etc.);
- Patients with mental disorders affecting clinical treatment or a history of central nervous system diseases;
- Patients with severe complications (intestinal obstruction, renal insufficiency, liver dysfunction, cerebrovascular disorders, etc.);
- Any toxicity of grade 2 or above from previous treatments that has not yet resolved (except for anemia, alopecia, and skin pigmentation);
- Any medical condition that is unstable or would affect patient safety and compliance with the study;
- Patients deemed unsuitable for participation in this clinical trial by the investigator.
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: Evaluation of the Efficiency and Safety of Stereotactic Body Radiation Therapy Combined With PD-1 Antibody in the Treatment of Unresectable Locally Recurrent Rectal Cancer: A Prospective, Multicenter, Single-Arm, Open Label, Phase II Study
This is a prospective study to delve into the therapeutic benefits of combining stereotactic body radiation therapy (SBRT) with PD-1 monoclonal antibody treatment for patients with unresectable locally recurrent rectal cancer (ULRRC). Our aim is to ascertain the safety of this approach and to offer robust, evidence-based medical guidance for the management of ULRRC using this innovative combination therapy.
Researchers will combine SBRT with PD-1 for ULRRC to see if this treatment can provide a benefit of survival.
Read more
Participants will:
- Receive chemotherapy combined with PD-1 therapy for 1 cycle → SBRT treatment → Chemotherapy combined with PD-1 therapy for 3-6 cycles (assessment 6 weeks after SBRT treatment) → Surgery/Maintenance therapy.
- Visit the clinic once every 3 months for checkups and tests
Read the detailed description
This clinical trial is a prospective, open-label, Phase II study. Patients with unresectable locally recurrent rectal cancer(ULRRC) by the multidisciplinary team (MDT) , and where the radiation oncology department within the MDT does not consider the presence of organs at risk (OARs) to affect the execution of SBRT, and who may benefit from improved progression-free survival or the creation of an R0 resection opportunity, are eligible for enrollment. Enrolled patients will receive high-dose fractionated radiotherapy of 5-8Gy per session, for a total of 5 sessions, with chemotherapy based on 5-FU before and after radiotherapy. Imaging assessments for surgical feasibility will be conducted 6 weeks (±2 weeks) after radiotherapy, and the MDT will decide on radical surgery, maintenance chemotherapy, or withdrawal 8 weeks (±2 weeks) after radiotherapy.
Participants will receive:
1 cycle of chemotherapy combined with PD-1 therapy → SBRT treatment → 3-6 cycles of chemotherapy combined with PD-1 therapy (assessed 6 weeks after SBRT treatment) → Surgery/Maintenance therapy.
Protocol of Stereotactic Body Radiation Therapy (SBRT):
Patients will begin SBRT treatment within 2 weeks after the first round of chemotherapy. Intensity-modulated radiation therapy (IMRT) technology will be used, with a target gross tumor volume (GTV) of 5-8Gy/5 sessions, a total dose of 25-40Gy equivalent to a biological effective dose (BED) of 37.5-72Gy, administered from Monday to Friday. For patients who have previously received pelvic radiotherapy, the re-irradiation dose will be 3-5Gy/5 sessions, a total dose of 15-25Gy equivalent to a BED of 19.5-37.5Gy, administered from Monday to Friday.
Protocol of PD-1 Monoclonal Antibody:
The PD-1 monoclonal antibody used is Sintilimab 200mg, administered intravenously on the first day.The study requires completion of at least 4 cycles of PD-1 monotherapy before and after SBRT to be considered eligible.
Protocol of Chemotherapy Regimen:
The choice of chemotherapy drugs will be at the discretion of the physician, based on the first-line chemotherapy regimen, using a second-line regimen primarily based on fluorouracil, such as a tri-weekly CAPOX or a bi-weekly mFOLFOX6/FOLFIRI/FOLFOXIRI + targeted therapy. Best supportive care will be provided during chemotherapy or chemoradiation.
Six weeks (±2 weeks) after the completion of high-dose fractionated radiotherapy, the MDT will assess patients through enhanced CT scans and pelvic MRI to determine disease resectability. If feasible, surgery will be performed 8 weeks (±2 weeks) after chemoradiation. The specific surgical approach depends on the location of recurrence and adjacent structures, as determined by the surgeon. Postoperative adjuvant chemotherapy will be administered based on the assessment by the MDT; if surgery is not possible, maintenance chemotherapy or withdrawal will be considered.
Patients who have completed the treatment or those who have not completed the treatment due to intolerable toxic reactions but have not shown tumor progression will be followed up every 3 months. The follow-up will include physical examinations, CT scans (every 3-6 months), pelvic MRI (3 months, 6 months, and the first year after SBRT treatment, then every 6-12 months thereafter), and colonoscopy examinations (once a year during the first, third, and fifth years of treatment). For patients who have already shown tumor progression, telephone follow-ups will be conducted every 3 months until death. During the follow-up, information on subsequent antitumor treatments and survival data of the patients will be collected.
- Being tested
- Stereotactic Body Radiation Therapy (SBRT), PD1, Chemotherapy
- Keywords
- Unresectable Locally Recurrent Rectal Cancer, Stereotactic Body Radiation Therapy, PD-1 monoclonal antibody
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic Body Radiation Therapy (SBRT)Radiation
Patients will begin SBRT treatment within 2 weeks after the first round of chemotherapy. Intensity-modulated radiation therapy (IMRT) technology will be used, with a target gross tumor volume (GTV) of 5-8Gy/5 sessions, a total dose of 25-40Gy equivalent to a biological effective dose (BED) of 37.5-72Gy, administered from Monday to Friday. For patients who have previously received pelvic radiotherapy, the re-irradiation dose will be 3-5Gy/5 sessions, a total dose of 15-25Gy equivalent to a BED of 19.5-37.5Gy, administered from Monday to Friday.
PD1Drug
The PD-1 monoclonal antibody used is Sintilimab 200mg every 3 weeks
ChemotherapyDrug
First-line chemotherapy regimen of rectal cancer, using a second-line regimen primarily based on fluorouracil, such as a tri-weekly CAPOX or a bi-weekly mFOLFOX6/FOLFIRI/FOLFOXIRI + targeted therapy
| Study group | Role | What they receive |
|---|---|---|
| SBRT+PD1 | Experimental | Participants of experimental arm (SBRT+PD-1 monotherapy group) will receive following treatments by sequences: Chemotherapy combined with PD-1 therapy for 1 cycle → SBRT treatment → Chemotherapy combined with PD-1 therapy for 3-6 cycles (assessment 6 weeks after SBRT treatment) → Surgery/Maintenance therapy. Receives: Radiation: Stereotactic Body Radiation Therapy (SBRT); Drug: PD1; Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
1 year PFS
1 year Progression-Free Survival Rate
Measured: 1 year
Secondary outcomes (7)
1 year OS
1 year Overall Survival Rate
Measured: 1 year
ORR
Overall Response Rate
Measured: 1 year
DCR
Disease Control Rate
Measured: 1 year
R0 resection rate
R0 resection rate in participants
Measured: 1 year
2 years PFS
2 years Local Progression-Free Survival Rate
Measured: 2 years
2 years OS
2 years Overall Survival Rate
Measured: 2 years
Acute Toxic Reaction
Acute Toxic Reaction of SBRT and PD-1 Therapy
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 posted9 Jan 2025
- Study start6 Jan 2025
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unresectable Locally Recurrent Rectal CancerStudies of the same condition, open and under way.
- More trials run by Sixth Affiliated Hospital, Sun Yat-sen 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Fudan University, Sun Yat-Sen University Cancer Center, Yunnan Cancer Hospital, Shenzhen People's Hospital
- Responsible party
- Principal investigator, Jun Huang, Sixth Affiliated Hospital, Sun Yat-sen University
- Investigators
- Jun Huang, MD, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06767007
- Sponsor's protocol ID
- E2024300
- Status last verified
- Apr 2026
- First submitted
- 4 Jan 2025
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficiency and Safety of Stereotactic Body Radiation Therapy Combined With PD-1 Antibody in the Treatment of Unresectable Locally Recurrent Rectal Cancer: A Prospective, Multicenter, Single-Arm, Open Label, Phase II Study
- ClinicalTrials.gov ID
- NCT06767007
- Acronym / sponsor ID
- E2024300
- Keywords
- Unresectable Locally Recurrent Rectal Cancer, Stereotactic Body Radiation Therapy, PD-1 monoclonal antibody
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Fudan University, Sun Yat-Sen University Cancer Center, Yunnan Cancer Hospital, Shenzhen People's Hospital
- Study start
- 6 Jan 2025 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 9 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.
This is a prospective study to delve into the therapeutic benefits of combining stereotactic body radiation therapy (SBRT) with PD-1 monoclonal antibody treatment for patients with unresectable locally recurrent rectal cancer (ULRRC). Our aim is to ascertain the safety of this approach and to offer robust, evidence-based medical guidance for the management of ULRRC using this innovative combination therapy.
Researchers will combine SBRT with PD-1 for ULRRC to see if this treatment can provide a benefit of survival.
Participants will:
- Receive chemotherapy combined with PD-1 therapy for 1 cycle → SBRT treatment → Chemotherapy combined with PD-1 therapy for 3-6 cycles (assessment 6 weeks after SBRT treatment) → Surgery/Maintenance therapy.
- Visit the clinic once every 3 months for checkups and tests
Detailed description
This clinical trial is a prospective, open-label, Phase II study. Patients with unresectable locally recurrent rectal cancer(ULRRC) by the multidisciplinary team (MDT) , and where the radiation oncology department within the MDT does not consider the presence of organs at risk (OARs) to affect the execution of SBRT, and who may benefit from improved progression-free survival or the creation of an R0 resection opportunity, are eligible for enrollment. Enrolled patients will receive high-dose fractionated radiotherapy of 5-8Gy per session, for a total of 5 sessions, with chemotherapy based on 5-FU before and after radiotherapy. Imaging assessments for surgical feasibility will be conducted 6 weeks (±2 weeks) after radiotherapy, and the MDT will decide on radical surgery, maintenance chemotherapy, or withdrawal 8 weeks (±2 weeks) after radiotherapy.
Participants will receive:
1 cycle of chemotherapy combined with PD-1 therapy → SBRT treatment → 3-6 cycles of chemotherapy combined with PD-1 therapy (assessed 6 weeks after SBRT treatment) → Surgery/Maintenance therapy.
Protocol of Stereotactic Body Radiation Therapy (SBRT):
Patients will begin SBRT treatment within 2 weeks after the first round of chemotherapy. Intensity-modulated radiation therapy (IMRT) technology will be used, with a target gross tumor volume (GTV) of 5-8Gy/5 sessions, a total dose of 25-40Gy equivalent to a biological effective dose (BED) of 37.5-72Gy, administered from Monday to Friday. For patients who have previously received pelvic radiotherapy, the re-irradiation dose will be 3-5Gy/5 sessions, a total dose of 15-25Gy equivalent to a BED of 19.5-37.5Gy, administered from Monday to Friday.
Protocol of PD-1 Monoclonal Antibody:
The PD-1 monoclonal antibody used is Sintilimab 200mg, administered intravenously on the first day.The study requires completion of at least 4 cycles of PD-1 monotherapy before and after SBRT to be considered eligible.
Protocol of Chemotherapy Regimen:
The choice of chemotherapy drugs will be at the discretion of the physician, based on the first-line chemotherapy regimen, using a second-line regimen primarily based on fluorouracil, such as a tri-weekly CAPOX or a bi-weekly mFOLFOX6/FOLFIRI/FOLFOXIRI + targeted therapy. Best supportive care will be provided during chemotherapy or chemoradiation.
Six weeks (±2 weeks) after the completion of high-dose fractionated radiotherapy, the MDT will assess patients through enhanced CT scans and pelvic MRI to determine disease resectability. If feasible, surgery will be performed 8 weeks (±2 weeks) after chemoradiation. The specific surgical approach depends on the location of recurrence and adjacent structures, as determined by the surgeon. Postoperative adjuvant chemotherapy will be administered based on the assessment by the MDT; if surgery is not possible, maintenance chemotherapy or withdrawal will be considered.
Patients who have completed the treatment or those who have not completed the treatment due to intolerable toxic reactions but have not shown tumor progression will be followed up every 3 months. The follow-up will include physical examinations, CT scans (every 3-6 months), pelvic MRI (3 months, 6 months, and the first year after SBRT treatment, then every 6-12 months thereafter), and colonoscopy examinations (once a year during the first, third, and fifth years of treatment). For patients who have already shown tumor progression, telephone follow-ups will be conducted every 3 months until death. During the follow-up, information on subsequent antitumor treatments and survival data of the patients will be collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SBRT+PD1 | Experimental | Radiation: Stereotactic Body Radiation Therapy (SBRT), Drug: PD1, Drug: ChemotherapyParticipants of experimental arm (SBRT+PD-1 monotherapy group) will receive following treatments by sequences: Chemotherapy combined with PD-1 therapy for 1 cycle → SBRT treatment → Chemotherapy combined with PD-1 therapy for 3-6 cycles (assessment 6 weeks after SBRT treatment) → Surgery/Maintenance therapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Before implementing procedures related to the research protocol rather than routine care, informed consent forms with the subject's voluntary signature and dated must be obtained in accordance with regulations and institutional guidelines;
- Patients with pMMR/MSS colorectal cancer;
- Age between 18 and 75 years;
- Tumor recurrence confirmed by histology, cytology, or imaging, and the multidisciplinary team (MDT) including surgeons assesses that the recurrent lesion cannot achieve a one-stage R0 resection (unresectable is defined as: 1. Pelvic MRI showing sacral infiltration at or above S2, 2. And/or lateral pelvic wall invasion, 3. And/or obturator vascular nerve infiltration, 4. After MDT discussion, there are no indications for a one-stage R0 resection, 5. The patient refuses total pelvic exenteration or debulking surgery);
- Locally recurrent rectal adenocarcinoma without clear distant metastasis at diagnosis/MDT team assesses oligometastases as resectable/controllable (UICC 8th edition);
Key exclusion criteria (19 listed)
- Patients with a history of severe drug allergies (including allergies to platinum-based agents, 5-FU, LV, and 5-HT3 receptor antagonists);
- Patients who have participated in or are currently participating in other clinical trials within 4 weeks of enrollment;
- History of receiving anti-PD-1, PD-L1, PD-L2, CTLA-4, or any other specific T-cell co-stimulation or checkpoint pathway targeted therapies;
- Severe electrolyte abnormalities;
- Presence of gastrointestinal diseases, such as active ulcers of the stomach or duodenum, ulcerative colitis, or unresected tumors with active bleeding; or other conditions that may lead to gastrointestinal bleeding or perforation; or gastrointestinal perforations that have not healed after surgical treatment;
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 Therapy (SBRT)Patients will begin SBRT treatment within 2 weeks after the first round of chemotherapy. Intensity-modulated radiation therapy (IMRT) technology will be used, with a target gross tumor volume (GTV) of 5-8Gy/5 sessions, a total dose of 25-40Gy equivalent to a biological effective dose (BED) of 37.5-72Gy, administered from Monday to Friday. For patients who have previously received pelvic radiotherapy, the re-irradiation dose will be 3-5Gy/5 sessions, a total dose of 15-25Gy equivalent to a BED of 19.5-37.5Gy, administered from Monday to Friday. | Radiation | SBRT+PD1 |
| PD1The PD-1 monoclonal antibody used is Sintilimab 200mg every 3 weeks | Drug | SBRT+PD1 |
| ChemotherapyFirst-line chemotherapy regimen of rectal cancer, using a second-line regimen primarily based on fluorouracil, such as a tri-weekly CAPOX or a bi-weekly mFOLFOX6/FOLFIRI/FOLFOXIRI + targeted therapy | Drug | SBRT+PD1 |
Primary outcome
1 year PFS
Time frame: 1 year
1 year Progression-Free Survival Rate
7 secondary outcomes
1 year OS
Time frame: 1 year
ORR
Time frame: 1 year
DCR
Time frame: 1 year
R0 resection rate
Time frame: 1 year
2 years PFS
Time frame: 2 years
2 years OS
Time frame: 2 years
Acute Toxic Reaction
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 23 Apr 2026.
- 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.
Jun Huang, MD 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 2 study testing Stereotactic Body Radiation Therapy (SBRT), PD1 and Chemotherapy in people with Unresectable Locally Recurrent Rectal Cancer, run by Sixth Affiliated Hospital, Sun Yat-sen 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 16 inclusion and 19 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 23 Apr 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Wang, M.D. (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?
1 year PFS (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 23 Apr 2026; AzTrials last refreshed its copy on 8 Nov 2026.