A Phase 2/3 interventional study of radiotherapy and Toripalimab in Rectal Cancer, sponsored by The First Hospital of Jilin University. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-13.
Sponsored by The First Hospital of Jilin University · Phase 2/3, Interventional, and Prevention
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Among 11 studies in Rectal Neoplasms by The First Hospital of Jilin University — 6 open to participants now, 7 under way, 2 of them phase 3. Rectal Neoplasms · The First Hospital of Jilin University.
Among the 11 studies in Rectal Neoplasms by The First Hospital of Jilin University, this one is the 9th largest by planned enrollment of the 10 interventional ones that give a count, is one of 2 that started in 2025, is one of 2 in phase 2/3, and was the 8th registered.
2,402 studies on the registry are indexed under Rectal Neoplasms; 589 are open to participants now.
Browse Rectal Neoplasms studies →6 of the 11 studies in Rectal Neoplasms by The First Hospital of Jilin University are open now, in 1 country. Recruiting first, the newest first:
The First Hospital of Jilin University · Sites in China
The First Hospital of Jilin University · Sites in China
Ages 18–75
The First Hospital of Jilin University · Sites in China
Ages 18–75
The First Hospital of Jilin University · Sites in China
Ages 18–75
The First Hospital of Jilin University · Sites in China
Ages 18–75
By country, each count listing its studies:
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 75 Years · all sexes · no healthy volunteers.
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11 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 1 · Phase 2 3 · Phase 3 2
First in 2021; this study’s year is marked. 2 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 32 is below the median of 65 across 1,753 interventional studies indexed under Rectal Neoplasms.
Median enrollment 136 across the 10 interventional studies, 300 across the 1 observational. Of the 2 that completed or were terminated, 0 (0%) have results posted.
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The First Hospital of Jilin University is the lead sponsor of 186 studies on the registry; 97 are open to participants now.
1 of the studies in Rectal Neoplasms by The First Hospital of Jilin University that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05998122The First Hospital of Jilin UniversityTotal Neoadjuvant Chemoradiotherapy Plus Anti-PD-1 in Subperitoneal Patients With Locally Advanced Rectal CancerPatients With Locally Advanced Rectal Cancer: A Prospective, Single Arm, Exploratory Study | 2026-12-31 |
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Among the 11 studies in Rectal Neoplasms by The First Hospital of Jilin University, from their registry updates:
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Why is this study conducted? The purpose of this study is to improve treatment efficacy, particularly the pathological complete response rate, in patients with high-risk/extremely high-risk locally advanced rectal cancer (LARC). While advances have been achieved with neoadjuvant chemoradiotherapy combined with immunotherapy in recent years, regional recurrence and distant metastasis remain unresolved. New therapeutic strategies for this patient population are therefore urgently needed.
Rectal cancer management typically includes surgery, radiation therapy and chemotherapy. Treatment paradigms are shifting toward neoadjuvant chemoradiotherapy plus immunotherapy, which has demonstrated promising potential in several clinical trials. These data indicate that short-course radiotherapy combined with anti-angiogenic agents and immune checkpoint inhibitors may improve patient prognosis and tumor response. Nevertheless, the efficacy and safety of this regimen in high-risk patients require further validation.
Against this background, the study evaluates a novel regimen of short-course radiotherapy followed by surufatinib and toripalimab (anti-PD-1) to raise the pathological complete response rate. The investigators also explore efficacy-related biomarkers including RAS/BRAF status and gene expression profiles to support personalized treatment. This study aims to optimize therapy for LARC patients and inform future treatment strategies.
Why are participants invited to participate in this study? Participants are considered eligible for enrollment upon diagnosis of high-risk or extremely high-risk locally advanced rectal cancer consistent with study inclusion criteria. Eligibility requires confirmed pathological diagnosis, appropriate tumor location, and absence of severe comorbidities or exclusionary diseases (e.g., recurrent rectal cancer, cardiac dysfunction). Final enrollment decisions are made by study physicians based on individual clinical conditions.
What do participants need to do to participate in this study? Study participation requires adherence to predefined procedures. Participants receive scheduled medical assessments including blood tests, imaging scans and anorectal function evaluation. During the study period, participants may complete questionnaires and provide biospecimens (e.g., blood samples) for efficacy analysis. The study team defines the frequency and content of each follow-up to maintain continuous monitoring throughout treatment. Compliance with study procedures supports evaluation of regimen efficacy.
What are the risks of participating in this study?
This study applies neoadjuvant short-course radiotherapy, anti-PD-1 monoclonal antibody (toripalimab), and anti-angiogenic therapy (surufatinib). Potential risks for participants are listed below:
Risk of neoadjuvant short-course radiotherapy: Participants may develop grade ≥3 adverse events including, but not limited to, severe diarrhea, grade 3 neutropenia and grade 3 radiation dermatitis, which may impair quality of life.
Risk of anti-PD-1 monoclonal antibody: Toripalimab may induce immune-related adverse events (irAEs) across organ systems. Common irAEs include skin toxicity (papules, pruritus; incidence 30%-40%), diarrhea/colitis (8%-19%), fatigue (16%-24%), immune-related hepatitis (5%), hypothyroidism (4%-10%), and hyperthyroidism (4%). Approximately two-thirds of patients receiving immune checkpoint inhibitors develop irAEs of varying severity, and serious adverse events are non-negligible.
Risk of anti-angiogenic therapy: Surufatinib may trigger adverse events related to anti-angiogenic and immunomodulatory effects. Common adverse events (incidence >20%) include proteinuria, hypertension, bleeding, liver dysfunction and diarrhea. Among grade ≥3 adverse events, hypertension (29.7%), proteinuria (14.5%), liver dysfunction (12.8%) and bleeding (4.5%) predominate. Rarely, treatment-related death may occur secondary to gastrointestinal hemorrhage or cerebral hemorrhage.
Handling of research related injuries? This interventional study introduces no extra risks beyond standard clinical care. Any harm arising from study participation will be addressed for compensation and liability in accordance with applicable laws and regulations.
Why is this study conducted? The purpose of this study is to improve treatment efficacy, particularly the pathological complete response rate, in patients with high-risk/extremely high-risk locally advanced rectal cancer (LARC). Recent advances have been achieved with neoadjuvant chemoradiotherapy combined with immunotherapy for rectal cancer, yet regional recurrence and distant metastasis remain persistent challenges. Developing novel therapeutic strategies for this patient population is therefore critical.
Rectal cancer management typically consists of surgery, radiation therapy, and chemotherapy. Treatment strategies are gradually shifting toward neoadjuvant chemoradiotherapy plus immunotherapy, which has demonstrated promising potential in multiple clinical trials. These trials indicate that combining short-course radiotherapy, anti-angiogenic agents, and immune checkpoint inhibitors may improve patient prognosis and increase tumor response rates. Nonetheless, the efficacy and safety of such regimens in high-risk patients require further validation.
Against this background, the study aims to evaluate a novel regimen: short-course radiotherapy followed by surufatinib and toripalimab (anti-PD-1), to increase the pathological complete response rate. The investigators also explore efficacy-associated biomarkers including RAS/BRAF status and gene expression profiles to support personalized treatment. This study seeks to optimize therapy for patients with LARC and inform future treatment approaches.
Why are participants invited to participate in this study? Participants are eligible for screening with a diagnosis of high-risk or extremely high-risk locally advanced rectal cancer that satisfies study inclusion criteria. Eligible candidates must have pathologically confirmed disease, appropriate tumor location, and no severe comorbidities or exclusionary illnesses (e.g., recurrent rectal cancer, cardiac dysfunction). Final enrollment decisions are made by study physicians based on individual clinical status.
What do participants need to do to participate in this study? Study participation requires adherence to predefined study procedures. Participants receive scheduled medical assessments, including blood tests, imaging scans, and anorectal function evaluations. During the study period, participants may complete questionnaires and provide biospecimens (e.g., blood samples) for treatment efficacy analysis. The study team defines the frequency and content of each follow-up to maintain continuous monitoring throughout treatment. Compliance with study procedures supports evaluation of regimen efficacy.
What are the risks of participating in this study?
This study applies neoadjuvant short-course radiotherapy, anti-PD-1 monoclonal antibody (toripalimab), and anti-angiogenic therapy (surufatinib). Potential risks for participants are listed below:
Risk of neoadjuvant short-course radiotherapy: Participants may develop grade ≥3 adverse events including, but not limited to, severe diarrhea, grade 3 neutropenia, and grade 3 radiation dermatitis, which may impair patient quality of life.
Risk of anti-PD-1 monoclonal antibody: Toripalimab may induce immune-related adverse events (irAEs) involving any organ system. Common irAEs include skin toxicity (papules, pruritus; incidence 30% to 40%), diarrhea and/or colitis (8% to 19%), fatigue (16% to 24%), immune-related hepatitis (5%), hypothyroidism (4% to 10%), and hyperthyroidism (4%). Approximately two-thirds of patients receiving immune checkpoint inhibitors develop irAEs of varying severity; the risk of serious adverse events cannot be overlooked.
Risk of anti-angiogenic therapy: Surufatinib may trigger adverse reactions related to its anti-angiogenic and immunomodulatory effects. Common adverse events (incidence >20%) include proteinuria, hypertension, bleeding, liver dysfunction, and diarrhea. Among grade ≥3 adverse events, hypertension (29.7%), proteinuria (14.5%), liver dysfunction (12.8%), and bleeding (4.5%) occur most frequently. Rarely, treatment-related death may result from gastrointestinal hemorrhage or cerebral hemorrhage.
Handling of research related injuries? This interventional study introduces no incremental risks beyond standard clinical diagnosis and treatment. Any harm arising from study participation will be reviewed for compensation and liability in accordance with applicable laws and regulations.
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.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
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.
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.
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.
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.
Radiation: radiotherapy · Drug: Toripalimab · Drug: Surufatinib 250mg/d qd once daily
Short-course preoperative radiotherapy (SCRT) for locally advanced rectal cancer.
Toripalimab 200 mg will be administered intravenously once every 21 days for 4 cycles.
Drug page: Surufatinib
Surufatinib 250 mg will be orally administered once daily during the first 3 cycles concurrently with toripalimab.
Pathologic complete response (pCR) rate
Pathologic complete response (pCR) rate is defined as the percentage of patients who achieve pCR after neoadjuvant therapy within the eligible population \[15\]. Pathologic complete response (pCR) is characterized by the absence of invasive cancer in the primary rectum and negative regional lymph nodes following adequate or complete sampling (ypT0N0, tumor regression grade \[TRG\] 0 points) \[16\]. Microscopically, cancer cells in the tumor bed are absent, with possible infiltration of inflammatory cells in the interstitium. Additionally, foamy cells and fibrous tissue proliferation may be observed. (For evaluation criteria, refer to the AJCC 8th Edition: Colorectal Cancer.)
Time frame: From baseline up to the time of surgery (approximately 14 weeks after radiotherapy initiation)
Plan to share: Undecided
No publications or documents are linked to this record.
Started May 2025 (actual). Primary completion is estimated for Dec 2028, 43 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drugs tested here: Toripalimab · Surufatinib
The First Hospital of Jilin University →