Unresectable Locally Recurrent Rectal CancerPhase 2NCT07297004
Stereotactic Body Radiation Therapy for Unresectable Locally Recurrent Rectal Cancer
A Phase 2 study testing Stereotactic Body Radiation Therapy (SBRT) in people with Unresectable Locally Recurrent Rectal Cancer, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
Trial summary
Research Objectives and Principles: Through a prospective study, explore the effectiveness and safety of stereotactic body radiation therapy (SBRT) in the treatment of unresectable locally recurrent rectal cancer (ULRRC), providing high-level evidence for the use of SBRT in ULRRC treatment. 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)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 30 Nov 2026
- 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
- Written informed consent;
- 18-75 years of age;
- Histologically, cytologically, or radiologically confirmed tumor recurrence, and the MDT assesses that the recurrent lesion cannot achieve R0 resection (unresectable defined as: 1) Pelvic MRI shows infiltration of S2 or above, 2) and/or lateral pelvic invasion, 3) and/or neurovascular invasion of the pelvic, 4) No indication for R0 resection after MDT discussion);
- No clear distant metastasis at the time of diagnosis of locally recurrent rectal adenocarcinoma or MDT assesses that oligometastatic lesions are resectable or controlable (UICC 8th edition);
- No previous radiotherapy for initial treatment, or more than 6 months between completion of initial radiotherapy and start of re-radiotherapy, with a previous radiotherapy dose of less than 50.4 Gy, and no grade 3-4 radiotherapy side effects in the small intestine or bladder;
- ECOG score for performance status is 0-1 (Appendix 1);
Show all 11Show fewer
- Peripheral blood cell counts and liver and kidney function within the following acceptable ranges (tested within 15 days before treatment):
- White blood cell count more than 3.0×10^9/L or neutrophils more than 1.5×10^9/L;
- Hemoglobin more than 80 g/L; ③ Platelets more than 100×10^9/L; ④ ALT or AST less than 3 times the upper limit of normal; ⑤ Total bilirubin less than 1.5 times the upper limit of normal; ⑥ Creatinine less than 1.5 times the upper limit of normal;
- No history of other malignant tumors, non-pregnant or lactating patients, participants must use effective contraception during the study and for 6 months after the last treatment;
- Expected survival more than 12 months.
Who cannot join
- Patients with a history of severe allergies to drugs, including platinum-based drugs, 5-FU, LV, and 5-HT3 receptor antagonists;
- Patients who have participated in or are participating in other clinical trials within 4 weeks of enrollment;
- Severe electrolyte abnormalities;
- Presence of gastrointestinal diseases, such as active ulcers in the stomach or duodenum, ulcerative colitis, or unresected tumors that are actively bleeding; or other conditions that may lead to gastrointestinal bleeding or perforation; or unhealed gastrointestinal perforation after surgical treatment;
- History of arterial thrombosis or deep vein thrombosis within 6 months; evidence of bleeding history or bleeding tendency within 2 months;
- Pregnant or lactating women or women with a positive pregnancy test before the first medication; or female participants and their partners unwilling to strictly use contraception during the study;
Show all 18Show fewer
- Brain metastases with a diameter greater than 3 cm or a total volume greater than 30 cc;
- Clinical or radiological evidence of spinal cord compression, or tumors within 3 mm of the spinal cord on MRI;
- History of other active malignant tumors (except for those who have received curative treatment and have been disease-free for over 3 years or in situ cancers that can be cured with adequate treatment);
- Severe ECG abnormalities, active coronary artery disease, or severe and uncontrolled angina, newly diagnosed angina, or myocardial infarction within 12 months before participating in the study, congestive heart failure of NYHA class II or above;
- Patients with active infections (fever above 38°C due to infection);
- Patients with poorly controlled hypercalcemia, high blood pressure, or 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 failure, liver failure, cerebrovascular disorders, etc.);
- Any unresolved toxicity from previous treatments that is grade 2 or higher according to CTCAE (excluding anemia, alopecia, skin pigmentation);
- Any medical condition that is unstable or may affect patient safety and study compliance;
- Patients deemed unsuitable for participation in this study 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
The Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510655
Jian Zhen, +862085655905, zhengj48@mail.sysu.edu.cn
About this study
Official title: Stereotactic Body Radiation Therapy for Unresectable Locally Recurrent Rectal Cancer: A Prospective, Single-arm, Phase II Study
Research Objectives and Principles: Through a prospective study, explore the effectiveness and safety of stereotactic body radiation therapy (SBRT) in the treatment of unresectable locally recurrent rectal cancer (ULRRC), providing high-level evidence for the use of SBRT in ULRRC treatment.
Primary Objective: 1-year local progression-free survival (LPFS) . Secondary Objectives: R0 resection rate and overall survival (OS), 2-year LPFS and OS, and side effects of the treatment.
Read more
Study Design: A single-arm, open-label, prospective phase II study. Study Population and Expected Enrollment: Patients with unresectable locally recurrent rectal adenocarcinoma, with an expected enrollment of 40 patients.
Scheduled Visits and Duration: December 2024 to November 2027. Trial Duration: December 2024 to November 2027. Intervention: SBRT for unresectable locally recurrent rectal cancer. Statistical Hypothesis: Enrolled patients are those with unresectable recurrent rectal cancer. Based on previous literature reports and retrospective clinical data from our center, it is hypothesized that the 1-year LPFS for patients with unresectable locally recurrent colorectal cancer who do not receive SBRT is 20%, while the 1-year LPFS for those receiving SBRT intervention is 40%. Using Simon's optimal two-stage study design, a single-arm study, with α set at 0.05 and 1-β at 0.80, and an expected loss to follow-up rate of 10%.
- Being tested
- Stereotactic Body Radiation Therapy (SBRT)
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
SBRT for unresectable locally recurrent rectal cancer
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | SBRT for unresectable locally recurrent rectal cancer Receives: Radiation: Stereotactic Body Radiation Therapy (SBRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year local progression-free survival (LPFS)
Measured: 1 year
Secondary outcomes (4)
R0 resection rate
Measured: 2 years
1-year overall survival (OS)
Measured: 1 year
2-year local progression-free survival (LPFS)
Measured: 2 years
2-year overall survival (OS)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study start1 Jan 2025
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- 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
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07297004
- Sponsor's protocol ID
- SBRT-ULRRC
- Status last verified
- Apr 2026
- First submitted
- 13 Feb 2025
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen H, Louie AV, Higginson DS, Palma DA, Colaco R, Sahgal A. Stereotactic Radiosurgery and Stereotactic Body Radiotherapy in the Management of Oligometastatic Disease. Clin Oncol (R Coll Radiol). 2020 Nov;32(11):713-727. doi: 10.1016/j.clon.2020.06.018. Epub 2020 Jul 24.
PubMed 32718762Brooks ED, Chang JY. Time to abandon single-site irradiation for inducing abscopal effects. Nat Rev Clin Oncol. 2019 Feb;16(2):123-135. doi: 10.1038/s41571-018-0119-7.
PubMed 30401936Dorr W, Gabrys D. The Principles and Practice of Re-irradiation in Clinical Oncology: An Overview. Clin Oncol (R Coll Radiol). 2018 Feb;30(2):67-72. doi: 10.1016/j.clon.2017.11.014. Epub 2017 Dec 9.
PubMed 29233574Dagoglu N, Mahadevan A, Nedea E, Poylin V, Nagle D. Stereotactic body radiotherapy (SBRT) reirradiation for pelvic recurrence from colorectal cancer. J Surg Oncol. 2015 Mar 15;111(4):478-82. doi: 10.1002/jso.23858. Epub 2015 Feb 2.
PubMed 25644071Susko M, Lee J, Salama J, Thomas S, Uronis H, Hsu D, Migaly J, Willett C, Czito B, Palta M. The Use of Re-irradiation in Locally Recurrent, Non-metastatic Rectal Cancer. Ann Surg Oncol. 2016 Oct;23(11):3609-3615. doi: 10.1245/s10434-016-5250-z. Epub 2016 May 11.
PubMed 27169769Denost Q, Frison E, Salut C, Sitta R, Rullier A, Harji D, Maillou-Martinaud H, Rullier E, Smith D, Vendrely V; on behalf the GRECCAR Group. A phase III randomized trial evaluating chemotherapy followed by pelvic reirradiation versus chemotherapy alone as preoperative treatment for locally recurrent rectal cancer - GRECCAR 15 trial protocol. Colorectal Dis. 2021 Jul;23(7):1909-1918. doi: 10.1111/codi.15670. Epub 2021 Jun 10.
PubMed 33843133PelvEx Collaborative. Induction chemotherapy followed by chemoradiotherapy versus chemoradiotherapy alone as neoadjuvant treatment for locally recurrent rectal cancer: study protocol of a multicentre, open-label, parallel-arms, randomized controlled study (PelvEx II). BJS Open. 2021 May 7;5(3):zrab029. doi: 10.1093/bjsopen/zrab029.
PubMed 34089596Nordkamp S, Voogt ELK, van Zoggel DMGI, Martling A, Holm T, Jansson Palmer G, Suzuki C, Nederend J, Kusters M, Burger JWA, Rutten HJT, Iversen H. Locally recurrent rectal cancer: oncological outcomes with different treatment strategies in two tertiary referral units. Br J Surg. 2022 Jun 14;109(7):623-631. doi: 10.1093/bjs/znac083.
PubMed 35416250Kusters M, Dresen RC, Martijn H, Nieuwenhuijzen GA, van de Velde CJ, van den Berg HA, Beets-Tan RG, Rutten HJ. Radicality of resection and survival after multimodality treatment is influenced by subsite of locally recurrent rectal cancer. Int J Radiat Oncol Biol Phys. 2009 Dec 1;75(5):1444-9. doi: 10.1016/j.ijrobp.2009.01.015. Epub 2009 Apr 22.
PubMed 19395199Sun DS, Zhang JD, Li L, Dai Y, Yu JM, Shao ZY. Accelerated hyperfractionation field-involved re-irradiation combined with concurrent capecitabine chemotherapy for locally recurrent and irresectable rectal cancer. Br J Radiol. 2012 Mar;85(1011):259-64. doi: 10.1259/bjr/28173562. Epub 2011 Mar 8.
PubMed 21385917Rahbari NN, Ulrich AB, Bruckner T, Munter M, Nickles A, Contin P, Loffler T, Reissfelder C, Koch M, Buchler MW, Weitz J. Surgery for locally recurrent rectal cancer in the era of total mesorectal excision: is there still a chance for cure? Ann Surg. 2011 Mar;253(3):522-33. doi: 10.1097/SLA.0b013e3182096d4f.
PubMed 21209587Yamada K, Ishizawa T, Niwa K, Chuman Y, Akiba S, Aikou T. Patterns of pelvic invasion are prognostic in the treatment of locally recurrent rectal cancer. Br J Surg. 2001 Jul;88(7):988-93. doi: 10.1046/j.0007-1323.2001.01811.x.
PubMed 11442533Moore HG, Shoup M, Riedel E, Minsky BD, Alektiar KM, Ercolani M, Paty PB, Wong WD, Guillem JG. Colorectal cancer pelvic recurrences: determinants of resectability. Dis Colon Rectum. 2004 Oct;47(10):1599-606. doi: 10.1007/s10350-004-0677-x.
PubMed 15540287Zhao J, Du CZ, Sun YS, Gu J. Patterns and prognosis of locally recurrent rectal cancer following multidisciplinary treatment. World J Gastroenterol. 2012 Dec 21;18(47):7015-20. doi: 10.3748/wjg.v18.i47.7015.
PubMed 23323002Westberg K, Palmer G, Hjern F, Johansson H, Holm T, Martling A. Management and prognosis of locally recurrent rectal cancer - A national population-based study. Eur J Surg Oncol. 2018 Jan;44(1):100-107. doi: 10.1016/j.ejso.2017.11.013. Epub 2017 Nov 26.
PubMed 29224985
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stereotactic Body Radiation Therapy for Unresectable Locally Recurrent Rectal Cancer: A Prospective, Single-arm, Phase II Study
- ClinicalTrials.gov ID
- NCT07297004
- Acronym / sponsor ID
- SBRT-ULRRC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 22 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.
Research Objectives and Principles: Through a prospective study, explore the effectiveness and safety of stereotactic body radiation therapy (SBRT) in the treatment of unresectable locally recurrent rectal cancer (ULRRC), providing high-level evidence for the use of SBRT in ULRRC treatment.
Primary Objective: 1-year local progression-free survival (LPFS) . Secondary Objectives: R0 resection rate and overall survival (OS), 2-year LPFS and OS, and side effects of the treatment.
Study Design: A single-arm, open-label, prospective phase II study. Study Population and Expected Enrollment: Patients with unresectable locally recurrent rectal adenocarcinoma, with an expected enrollment of 40 patients.
Scheduled Visits and Duration: December 2024 to November 2027. Trial Duration: December 2024 to November 2027. Intervention: SBRT for unresectable locally recurrent rectal cancer. Statistical Hypothesis: Enrolled patients are those with unresectable recurrent rectal cancer. Based on previous literature reports and retrospective clinical data from our center, it is hypothesized that the 1-year LPFS for patients with unresectable locally recurrent colorectal cancer who do not receive SBRT is 20%, while the 1-year LPFS for those receiving SBRT intervention is 40%. Using Simon's optimal two-stage study design, a single-arm study, with α set at 0.05 and 1-β at 0.80, and an expected loss to follow-up rate of 10%.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Radiation: Stereotactic Body Radiation Therapy (SBRT)SBRT for unresectable locally recurrent rectal cancer |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Written informed consent;
- 18-75 years of age;
- Histologically, cytologically, or radiologically confirmed tumor recurrence, and the MDT assesses that the recurrent lesion cannot achieve R0 resection (unresectable defined as: 1) Pelvic MRI shows infiltration of S2 or above, 2) and/or lateral pelvic invasion, 3) and/or neurovascular invasion of the pelvic, 4) No indication for R0 resection after MDT discussion);
- No clear distant metastasis at the time of diagnosis of locally recurrent rectal adenocarcinoma or MDT assesses that oligometastatic lesions are resectable or controlable (UICC 8th edition);
- No previous radiotherapy for initial treatment, or more than 6 months between completion of initial radiotherapy and start of re-radiotherapy, with a previous radiotherapy dose of less than 50.4 Gy, and no grade 3-4 radiotherapy side effects in the small intestine or bladder;
Key exclusion criteria (18 listed)
- Patients with a history of severe allergies to drugs, including platinum-based drugs, 5-FU, LV, and 5-HT3 receptor antagonists;
- Patients who have participated in or are participating in other clinical trials within 4 weeks of enrollment;
- Severe electrolyte abnormalities;
- Presence of gastrointestinal diseases, such as active ulcers in the stomach or duodenum, ulcerative colitis, or unresected tumors that are actively bleeding; or other conditions that may lead to gastrointestinal bleeding or perforation; or unhealed gastrointestinal perforation after surgical treatment;
- History of arterial thrombosis or deep vein thrombosis within 6 months; evidence of bleeding history or bleeding tendency within 2 months;
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)SBRT for unresectable locally recurrent rectal cancer | Radiation | Experimental group |
Primary outcome
1-year local progression-free survival (LPFS)
Time frame: 1 year
4 secondary outcomes
R0 resection rate
Time frame: 2 years
1-year overall survival (OS)
Time frame: 1 year
2-year local progression-free survival (LPFS)
Time frame: 2 years
2-year overall survival (OS)
Time frame: 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 24 Apr 2026.
- Results publication: PubMed 32718762Chen H, Louie AV, Higginson DS, Palma DA, Colaco R, Sahgal A. Stereotactic Radiosurgery and Stereotactic Body Radiotherapy in the Management of Oligometastatic Disease. Clin Oncol (R Coll Radiol). 2020 Nov;32(11):713-727. doi: 10.1016/j.clon.2020.06.018. Epub 2020 Jul 24.
- Results publication: PubMed 30401936Brooks ED, Chang JY. Time to abandon single-site irradiation for inducing abscopal effects. Nat Rev Clin Oncol. 2019 Feb;16(2):123-135. doi: 10.1038/s41571-018-0119-7.
- Results publication: PubMed 29233574Dorr W, Gabrys D. The Principles and Practice of Re-irradiation in Clinical Oncology: An Overview. Clin Oncol (R Coll Radiol). 2018 Feb;30(2):67-72. doi: 10.1016/j.clon.2017.11.014. Epub 2017 Dec 9.
- Results publication: PubMed 25644071Dagoglu N, Mahadevan A, Nedea E, Poylin V, Nagle D. Stereotactic body radiotherapy (SBRT) reirradiation for pelvic recurrence from colorectal cancer. J Surg Oncol. 2015 Mar 15;111(4):478-82. doi: 10.1002/jso.23858. Epub 2015 Feb 2.
- Results publication: PubMed 27169769Susko M, Lee J, Salama J, Thomas S, Uronis H, Hsu D, Migaly J, Willett C, Czito B, Palta M. The Use of Re-irradiation in Locally Recurrent, Non-metastatic Rectal Cancer. Ann Surg Oncol. 2016 Oct;23(11):3609-3615. doi: 10.1245/s10434-016-5250-z. Epub 2016 May 11.
- Results publication: PubMed 33843133Denost Q, Frison E, Salut C, Sitta R, Rullier A, Harji D, Maillou-Martinaud H, Rullier E, Smith D, Vendrely V; on behalf the GRECCAR Group. A phase III randomized trial evaluating chemotherapy followed by pelvic reirradiation versus chemotherapy alone as preoperative treatment for locally recurrent rectal cancer - GRECCAR 15 trial protocol. Colorectal Dis. 2021 Jul;23(7):1909-1918. doi: 10.1111/codi.15670. Epub 2021 Jun 10.
- Results publication: PubMed 34089596PelvEx Collaborative. Induction chemotherapy followed by chemoradiotherapy versus chemoradiotherapy alone as neoadjuvant treatment for locally recurrent rectal cancer: study protocol of a multicentre, open-label, parallel-arms, randomized controlled study (PelvEx II). BJS Open. 2021 May 7;5(3):zrab029. doi: 10.1093/bjsopen/zrab029.
- Results publication: PubMed 35416250Nordkamp S, Voogt ELK, van Zoggel DMGI, Martling A, Holm T, Jansson Palmer G, Suzuki C, Nederend J, Kusters M, Burger JWA, Rutten HJT, Iversen H. Locally recurrent rectal cancer: oncological outcomes with different treatment strategies in two tertiary referral units. Br J Surg. 2022 Jun 14;109(7):623-631. doi: 10.1093/bjs/znac083.
- Results publication: PubMed 19395199Kusters M, Dresen RC, Martijn H, Nieuwenhuijzen GA, van de Velde CJ, van den Berg HA, Beets-Tan RG, Rutten HJ. Radicality of resection and survival after multimodality treatment is influenced by subsite of locally recurrent rectal cancer. Int J Radiat Oncol Biol Phys. 2009 Dec 1;75(5):1444-9. doi: 10.1016/j.ijrobp.2009.01.015. Epub 2009 Apr 22.
- Results publication: PubMed 21385917Sun DS, Zhang JD, Li L, Dai Y, Yu JM, Shao ZY. Accelerated hyperfractionation field-involved re-irradiation combined with concurrent capecitabine chemotherapy for locally recurrent and irresectable rectal cancer. Br J Radiol. 2012 Mar;85(1011):259-64. doi: 10.1259/bjr/28173562. Epub 2011 Mar 8.
- Results publication: PubMed 21209587Rahbari NN, Ulrich AB, Bruckner T, Munter M, Nickles A, Contin P, Loffler T, Reissfelder C, Koch M, Buchler MW, Weitz J. Surgery for locally recurrent rectal cancer in the era of total mesorectal excision: is there still a chance for cure? Ann Surg. 2011 Mar;253(3):522-33. doi: 10.1097/SLA.0b013e3182096d4f.
- Results publication: PubMed 11442533Yamada K, Ishizawa T, Niwa K, Chuman Y, Akiba S, Aikou T. Patterns of pelvic invasion are prognostic in the treatment of locally recurrent rectal cancer. Br J Surg. 2001 Jul;88(7):988-93. doi: 10.1046/j.0007-1323.2001.01811.x.
- Individual participant dataSharing planned: No
Related trials for Unresectable Locally Recurrent Rectal Cancer
Recruiting
Radiotherapy Dose Escalation for Non-operative Management of Unresectable Locally Recurrent Rectal Cancer (STEP-UP)
Locally Recurrent Rectal Cancer
RecruitingPhase 2
Comparison of In-Home Versus In-Clinic Administration of Subcutaneous Nivolumab Through Cancer CARE (Connected Access and Remote Expertise) Beyond Walls (CCBW) Program
Advanced Esophageal Squamous Cell Carcinoma, Advanced Renal Cell Carcinoma
Recruiting
Association Between Health Care Provider (HCP)-Assessed ECOG Performance Status (PS) and Overall Survival, and Objectively Measure of Physical Activity (PA) Levels in Advance-cancer Patients"
Malignant Head and Neck Neoplasm, Malignant Neoplasm
RecruitingPhase 1/2
A Study to Evaluate the Safety and Efficacy of Mesothelin-Targeting Logic-gated CAR T, in Participants With Solid Tumors That Express MSLN and Have Lost HLA-A*02 Expression
Solid Tumor, Adult, Colorectal Cancer
RecruitingPhase 2
SBRT + PD-1 Antibody in Unresectable Locally Recurrent Rectal Cancer（SPARKLE）
Unresectable Locally Recurrent Rectal Cancer
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.
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) 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 11 inclusion and 18 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 24 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 Jian Zheng (+862085655905, zhengj48@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 local progression-free survival (LPFS) (time frame: 1 year). 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 NCT07297004, which also lists 23 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 24 Apr 2026.