A Phase 3 interventional study of Short-Course Radiotherapy and Consolidation treatment (With ICIs) in Local Advanced Rectal Cancer, Radiotherapy and Immunotherapy, sponsored by Shandong Cancer Hospital and Institute. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-18.
Sponsored by Shandong Cancer Hospital and Institute · Phase 3, 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 117th largest by planned enrollment of the 372 interventional ones that give a count, is one of 50 that started in 2026, is one of 41 in phase 3, reaches primary completion later than 241 of the 265 other live ones, and was the 443rd 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:
Tianjin Medical University Cancer Institute and Hospital · Sites in China
Ages 18–80
Fujian Cancer Hospital · 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 75 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 180 is above 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:
Shandong Cancer Hospital and Institute is the lead sponsor of 105 studies on the registry; 38 are open to participants now.
Shandong Cancer Hospital and Institute has 4 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 multicenter, randomized, controlled, phase III trial evaluates whether adding iparomlimab and tuvonralimab injection to CAPOX consolidation chemotherapy after short-course radiotherapy improves tumor response in patients with treatment-naive, proficient mismatch repair/microsatellite-stable (pMMR/MSS) locally advanced rectal adenocarcinoma. Eligible patients will be randomly assigned in a 1:1 ratio to receive short-course radiotherapy followed by CAPOX plus iparomlimab and tuvonralimab, or short-course radiotherapy followed by CAPOX alone.
After total neoadjuvant therapy, patients with a clinical complete response may undergo a Watch-and-Wait strategy, whereas other patients will undergo total mesorectal excision according to standard clinical practice. The primary endpoint is complete response rate, defined as pathologic complete response after surgery or clinical complete response sustained for more than 1 year. Secondary endpoints include 3-year relapse-free survival, 3-year overall survival, sphincter preservation rate, and grade 3-4 acute adverse events. Exploratory analyses will assess tissue and blood biomarkers associated with treatment response.
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.
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.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
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.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short-Course Radiotherapy + CAPOX + Iparomlimab and Tuvonralimab Radiotherapy: Short-course external-beam radiotherapy will be delivered to the rectal primary tumor and corresponding lymphatic drainage regions using IMRT or VMAT. The prescribed dose is 25 Gy in 5 fractions over 1 week. No concurrent chemotherapy will be administered during short-course radiotherapy. Consolidation treatment: Iparomlimab and tuvonralimab injection will be administered at 5 mg/kg by intravenous infusion every 21 days for 6 cycles. CAPOX chemotherapy will consist of oxaliplatin 130 mg/m² intravenously on day 1 plus capecitabine 1000 mg/m² orally twice daily on days 1-14 of each 21-day cycle, for 6 cycles.
Radiation: Short-Course Radiotherapy · Drug: Consolidation treatment (With ICIs)
Short-Course Radiotherapy + CAPOX Radiotherapy: Short-course external-beam radiotherapy will be delivered to the rectal primary tumor and corresponding lymphatic drainage regions using IMRT or VMAT. The prescribed dose is 25 Gy in 5 fractions over 1 week. No concurrent chemotherapy will be administered during short-course radiotherapy. Consolidation treatment: CAPOX chemotherapy will consist of oxaliplatin 130 mg/m² intravenously on day 1 plus capecitabine 1000 mg/m² orally twice daily on days 1-14 of each 21-day cycle, for 6 cycles.
Radiation: Short-Course Radiotherapy · Drug: Consolidation treatment (Without ICIs)
Short-course external-beam radiotherapy will be delivered to the rectal primary tumor and corresponding lymphatic drainage regions using IMRT or VMAT. The prescribed dose is 25 Gy in 5 fractions over 1 week. No concurrent chemotherapy will be administered during short-course radiotherapy.
Iparomlimab and tuvonralimab injection will be administered at 5 mg/kg by intravenous infusion every 21 days for 6 cycles. CAPOX chemotherapy will consist of oxaliplatin 130 mg/m² intravenously on day 1 plus capecitabine 1000 mg/m² orally twice daily on days 1-14 of each 21-day cycle, for 6 cycles.
CAPOX chemotherapy will consist of oxaliplatin 130 mg/m² intravenously on day 1 plus capecitabine 1000 mg/m² orally twice daily on days 1-14 of each 21-day cycle, for 6 cycles.
Complete Response (CR) Rate
Complete response rate is defined as the proportion of patients who achieve either pathologic complete response (pCR) after surgery or sustained clinical complete response (cCR) for more than 1 year during Watch-and-Wait follow-up.
Time frame: From randomization to completion of definitive response assessment, including surgical pathological assessment after total neoadjuvant therapy or confirmation of sustained clinical complete response after at least 12 months of Watch-and-Wait follow-up
3-Year Relapse-Free Survival (RFS)
Relapse-free survival is defined as the time from randomization to the first evidence of disease relapse or recurrence. Patients without relapse/recurrence or death will be censored at the date of last disease assessment.
Time frame: From randomization to the first documented disease relapse/recurrence, death from any cause, or 3 years after randomization, whichever occurs first.
3-Year Overall Survival (OS)
Overall survival is defined as the time from randomization to death from any cause. Patients who are alive at the time of analysis will be censored at the date of last known survival follow-up.
Time frame: From randomization to death from any cause or 3 years after randomization, whichever occurs first.
Sphincter Preservation Rate
Sphincter preservation rate is defined as the proportion of patients who successfully preserve anal sphincter structure and function and avoid permanent colostomy.
Time frame: From randomization to completion of definitive surgery, or to at least 12 months after initiation of Watch-and-Wait follow-up for patients who do not undergo surgery; approximately up to 18-24 months after randomization.
Incidence of Grade 3-4 Acute Adverse Events
Acute adverse events will be graded and recorded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0. The incidence of grade 3-4 acute adverse events will be summarized by treatment arm.
Time frame: From the start of study treatment to 30 days after completion of neoadjuvant treatment.
Plan to share: No
No publications or documents are linked to this record.
Started Aug 2026 (actual). Primary completion is estimated for Jul 2029, 35 months after the start.
Of 73 non-industry phase 3 interventional studies under Rectal Neoplasms, half reached primary completion within 76 months of starting (the median), counting those still running; a quarter within 38 and three quarters within 104. This study's planned 35 months is below that.
Counting every sponsor, half of 81 studies reached it within 59 months; a quarter within 37 and three quarters within 95.
How these figures are worked out, and which studies are left out of them.
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Shandong Cancer Hospital and Institute →