An interventional study of High-Dose-Rate Endorectal Brachytherapy in Rectal Cancer, Adenocarcinoma, sponsored by Tianjin Medical University Cancer Institute and Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by Tianjin Medical University Cancer Institute and Hospital · Not applicable, Interventional, and Treatment
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Among 462 studies in Rectal Neoplasms with a site in China — 227 open to participants now, 266 under way, 42 of them phase 3. Rectal Neoplasms · China.
Among the 462 studies in Rectal Neoplasms with a site in China, this one is the 259th largest by planned enrollment of the 372 interventional ones that give a count, is one of 50 that started in 2026, is one of 132 with no phase, reaches primary completion later than 244 of the 265 other live ones, and was the 451st registered.
2,402 studies on the registry are indexed under Rectal Neoplasms; 589 are open to participants now.
Browse Rectal Neoplasms studies →227 of the 462 studies in Rectal Neoplasms with a site in China are open now. Recruiting first, the newest first:
Fujian Cancer Hospital · Sites in China
Ages 18–75
Shandong Cancer Hospital and Institute · Sites in China
Ages 18–75
Shandong Cancer Hospital and Institute · Sites in China
Ages 18+
Shenzhen Ionova Life Sciences Co., Ltd. · Sites in China
Ages 18+
Changhai Hospital · Sites in China
Ages 18–75
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 405 Rectal Neoplasms studies recruiting now, 210 (52%) set no upper age limit and 143 (35%) stop at 75 or younger; 19 take children under 18; 16 take healthy volunteers.
This study: 18 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
462 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 24 · Phase 2 182 · Phase 3 56 · Phase 4 6
First in 1993; this study’s year is marked. 50 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 50 is below the median of 65 across 1,753 interventional studies indexed under Rectal Neoplasms.
Median enrollment 100 across the 372 interventional studies, 200 across the 89 observational. Of the 89 that completed or were terminated, 4 (4%) have results posted.
This tab as a report to print or save as PDF → With an account.
20 of 462 have an industry lead sponsor. The 10 most frequent:
Tianjin Medical University Cancer Institute and Hospital is the lead sponsor of 494 studies on the registry; 293 are open to participants now.
Tianjin Medical University Cancer Institute and Hospital has 5 studies filed under Rectal Neoplasms — fewer than ten, so there is no comparison to draw.
57 of the studies in Rectal Neoplasms with a site in China that are under way reach primary completion within a year, 5 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07537998Phase 3Pei-Rong DingAntegrade Intestinal Fluid Reinfusion for Prevention of Low Anterior Resection Syndrome After Low Anterior Resection: a Single-Center, Prospective Randomized Controlled Trial. | 2027-04-10 |
| NCT06850090Phase 3Shandong Cancer Hospital and InstituteNeoadjuvant Radiotherapy for Rectal Adenocarcinoma With Capecitabine Versus TAS-102 (Neo-REACT): A Multi-center, Randomized, Phase III Trial | 2027-06 |
| NCT07020247Phase 3West China HospitalPersonalized Long-course Radiotherapy Plus Chemotherapy With or Without Immunotherapy for LARC: PALACE Study | 2027-07-31 |
| NCT07134218Phase 3Changhai HospitalNeoadjuvant Chemoradiotherapy Combined With Immunotherapy and Anti-angiogenesis in Treating Locally Advanced Rectal Cancer | 2027-10 |
| NCT06229041Phase 3Peking University Cancer Hospital & InstituteTotal Neoadjuvant Treatment ±Immunotherapy for High Risk Locally Advanced Rectal Cancer (TNTi) | 2027-10-01 |
Add all 57 to your calendar (.ics) → With an account.
Among the 462 studies in Rectal Neoplasms with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This prospective, single-center, single-arm phase II study will evaluate the efficacy, safety, and technical feasibility of an organ-preserving radiotherapy strategy for patients with localized rectal adenocarcinoma who are medically inoperable, decline radical surgery, or are considered technically unresectable without distant metastases.
Participants will receive pelvic external beam radiotherapy followed by high-dose-rate (HDR) endorectal brachytherapy. Concurrent capecitabine may be given during external beam radiotherapy to participants who are considered able to tolerate chemotherapy. During HDR brachytherapy, all participants will be treated using a patient-specific 3D-printed guide template and individualized tungsten-alloy local shielding. The guide template is designed to improve applicator positioning and treatment reproducibility, while the local shielding is intended to reduce radiation exposure to non-target rectal wall.
The study will enroll 50 participants. The primary objectives are to evaluate the 12-month clinical complete response rate and the technical completion rate of the HDR brachytherapy platform. Secondary assessments include organ preservation, local regrowth, survival outcomes, treatment-related toxicity, quality of life, and anorectal function.
This investigator-initiated study is a prospective, open-label, single-arm phase II trial evaluating a definitive non-operative treatment strategy for localized rectal cancer. Eligible participants will have histologically confirmed rectal adenocarcinoma without distant metastases and will be considered medically unsuitable for radical surgery, decline radical surgery after appropriate counseling, or be considered technically unresectable by multidisciplinary assessment.
Following baseline evaluation and multidisciplinary review, participants will receive pelvic external beam radiotherapy. The planned dose to the pelvic planning target volume is 45 Gy in 25 fractions. Radiologically positive or highly suspicious lymph nodes will receive a simultaneous integrated boost to 55 Gy in 25 fractions, with escalation to 58-58.25 Gy in 25 fractions permitted when considered dosimetrically safe. Concurrent capecitabine at 825 mg/m² twice daily on radiotherapy days may be administered to participants who are considered able to tolerate chemotherapy; concurrent chemotherapy is not mandatory in this study.
Participants will undergo reassessment approximately 4-6 weeks after completion of external beam radiotherapy before proceeding to HDR endorectal brachytherapy. The planned HDR boost is 6 Gy per fraction for 3 fractions using an iridium-192 source, with fractions generally separated by 5-7 days.
During all HDR fractions, a patient-specific 3D-printed guide template will be used for applicator positioning, fixation, and reproducibility. Individualized flexible tungsten-alloy shielding, typically approximately 3 mm thick, will be positioned within a predefined channel in the template before treatment. The shielding configuration will be individualized according to tumor distribution and the location of non-target rectal wall requiring protection. Because the shielding material may produce substantial computed tomography artifacts, treatment planning will be performed before placement of the tungsten-alloy shielding, followed by verification of shielding direction, depth, and fixation before irradiation.
Tumor response will be assessed using a combination of digital rectal examination, endoscopy, and pelvic magnetic resonance imaging. Participants achieving a clinical complete response will enter a structured watch-and-wait follow-up program. Participants with residual disease, local regrowth, or progression will undergo multidisciplinary reassessment for individualized salvage treatment when appropriate.
In addition to clinical response and organ-preservation outcomes, the study will prospectively evaluate treatment-related toxicity and the technical performance of the individualized brachytherapy platform, including treatment completion, geometric reproducibility, shielding implementation, and dosimetric parameters.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive definitive organ-preserving treatment for rectal cancer, including external beam radiotherapy with concurrent chemotherapy as clinically indicated, followed by high-dose-rate brachytherapy for local dose intensification. Patient-specific treatment planning and study-specific brachytherapy techniques will be performed according to the study protocol.
Radiation: High-Dose-Rate Endorectal Brachytherapy
High-dose-rate (HDR) endorectal brachytherapy will be delivered as a local dose-intensification component of the organ-preserving treatment strategy for rectal cancer. Brachytherapy will be performed using image-guided, patient-specific treatment planning to optimize target coverage while limiting radiation exposure to adjacent organs at risk. Treatment technique, applicator placement, dose prescription, and fractionation will be performed according to the study protocol.
12-Month Clinical Complete Response Rate
Percentage of participants who maintain a clinical complete response (cCR) at 12 months after completion of study treatment, without local regrowth and without rectal cancer-related salvage resection. Clinical response will be assessed using a composite evaluation including digital rectal examination, endoscopy, and pelvic magnetic resonance imaging.
Time frame: From completion of study treatment through 12 months
Technical Completion Rate of HDR Brachytherapy
Percentage of participants who complete all three planned high-dose-rate (HDR) endorectal brachytherapy fractions using the study-specific 3D-printed individualized guide template and tungsten alloy local shielding platform as required by the study protocol.
Time frame: Through completion of HDR brachytherapy, approximately 8-10 weeks after completion of external beam radiotherapy
Overall Clinical Complete Response Rate
Percentage of participants who achieve a clinical complete response (cCR) after completion of study treatment. Clinical response will be assessed using a composite evaluation including digital rectal examination, endoscopy, and pelvic magnetic resonance imaging.
Time frame: From completion of study treatment through 12 months
Near-Clinical Complete Response Rate
Percentage of participants classified as having a near-clinical complete response (near-cCR) after completion of study treatment based on composite assessment using digital rectal examination, endoscopy, and pelvic magnetic resonance imaging.
Time frame: From completion of study treatment through 12 months
12-Month Organ Preservation Rate
Percentage of participants who remain alive with the rectum in situ and without rectal cancer-related radical salvage resection at 12 months after completion of study treatment.
Time frame: From completion of study treatment through 12 months
Local Regrowth Rate
Percentage of participants who develop local tumor regrowth after achieving a clinical complete response or near-clinical complete response during follow-up. Local regrowth will be assessed using digital rectal examination, endoscopy, pelvic magnetic resonance imaging, and other clinically indicated assessments.
Time frame: From completion of study treatment through 24 months
Local Failure-Free Survival
Time from completion of study treatment to the first occurrence of local treatment failure or death, whichever occurs first.
Time frame: from enrollment through 24 months
Progression-Free Survival
Time from completion of study treatment to the first documented disease progression, local or distant recurrence, or death from any cause, whichever occurs first.
Time frame: from enrollment through 24 months
Overall Survival
Time from completion of study treatment to death from any cause.
Time frame: from enrollment through 24 months
Stoma-Free Survival
Time from completion of study treatment to permanent stoma creation or death from any cause, whichever occurs first.
Time frame: from enrollment through 24 months
Incidence of Acute Treatment-Related Adverse Events
Percentage of participants experiencing acute treatment-related adverse events, with particular attention to grade 3 or higher gastrointestinal toxicity, bleeding, pain, ulceration, stenosis, and treatment-related functional impairment. Adverse events will be graded according to NCI-CTCAE version 5.0.
Time frame: From initiation of study treatment through 90 days after completion of study treatment
Incidence of Late Treatment-Related Adverse Events
Percentage of participants experiencing late treatment-related adverse events, with particular attention to grade 3 or higher gastrointestinal toxicity, rectal bleeding, ulceration, stenosis, pain, and treatment-related functional impairment. Adverse events will be graded according to NCI-CTCAE version 5.0.
Time frame: From more than 90 days after completion of study treatment through 24 months
Plan to share: No — Individual participant data (IPD) will not be publicly shared due to participant privacy and data protection considerations. Aggregate study results will be reported through scientific publications and/or presentations.
Started Sep 2026 (actual). Primary completion is estimated for Nov 2029, 38 months after the start.
Of 329 non-industry interventional studies with no phase under Rectal Neoplasms, half reached primary completion within 51 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 78. This study's planned 38 months is below that.
Counting every sponsor, half of 336 studies reached it within 51 months; a quarter within 23 and three quarters within 78.
How these figures are worked out, and which studies are left out of them.
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Tianjin Medical University Cancer Institute and Hospital →