A Phase 2 interventional study of Short-course radiotherapy and Capecitabine in Rectal Cancer, Radiotherapy and Immunotherapy, sponsored by Tao Zhang. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-06.
Sponsored by Tao Zhang · Phase 2, Interventional, and Treatment
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Among 146 studies testing Immune checkpoint inhibitors in Rectal Neoplasms — 90 open to participants now, 110 under way, 15 of them phase 3. A drug class: Immune checkpoint inhibitors · Rectal Neoplasms.
Among the 146 studies testing Immune checkpoint inhibitors in Rectal Neoplasms, this one is the 23rd largest by planned enrollment, is one of 26 that started in 2026, is one of 113 in phase 2, reaches primary completion later than 61 of the 109 other live ones, and was the 141st registered.
2,402 studies on the registry are indexed under Rectal Neoplasms; 589 are open to participants now.
Browse Rectal Neoplasms studies →90 of the 146 studies testing Immune checkpoint inhibitors in Rectal Neoplasms are open now, in 8 countries. Recruiting first, the newest first:
Columbia University · Sites in United States
Ages 18+
Dr. Te Vuong · Sites in Canada
Ages 18+
Dana-Farber Cancer Institute · Sites in United States
Ages 18+
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Sites in United States
Ages 18+
City of Hope Medical Center · Sites in United States
Ages 18+
By country, each count listing its studies:
A class of medicines: which ones, and the studies of each, are on its page →
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.
146 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 14 · Phase 2 125 · Phase 3 15
First in 2013; this study’s year is marked. 26 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 144 is above the median of 65 across 1,753 interventional studies indexed under Rectal Neoplasms.
Median enrollment 49 across the 146 interventional studies. Of the 22 that completed or were terminated, 3 (14%) have results posted.
This tab as a report to print or save as PDF → With an account.
7 of 146 have an industry lead sponsor. The 10 most frequent:
Tao Zhang is the lead sponsor of 17 studies on the registry; 10 are open to participants now.
Tao Zhang has 3 studies filed under Rectal Neoplasms — fewer than ten, so there is no comparison to draw.
20 of the studies testing Immune checkpoint inhibitors in Rectal Neoplasms that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04165772Memorial Sloan Kettering Cancer CenterStudy of Induction PD-1 Blockade in Subjects With Locally Advanced Mismatch Repair Deficient Solid Tumors | 2026-11-30 |
| NCT05024097Weill Medical College of Cornell UniversityA Phase I-II Study to Test the Safety and Efficacy of PD1 (AB122) and Adenosine Receptor (AB928) Antagonists With Chemotherapy After Short-Course Radiation for Rectal Cancer. | 2026-12 |
| NCT06647680The Affiliated Hospital of Qingdao UniversityNeoadjuvant Chemotherapy and PD-1 Inhibitor for Locally Advanced Rectal Cancer（CONTROL-01） | 2026-12-01 |
| NCT06787183Fujian Cancer HospitalSCRT(Short Course Radiotherapy) Combined With CAPOX Plus QL1706 for Rectal Cancer Liver Metastases | 2026-12-01 |
| NCT05731726Zhejiang UniversitySerplulimab Combined With CAPEOX + Celecoxib as Neoadjuvant Treatment for Locally Advanced Rectal Cancer | 2026-12-30 |
Add all 20 to your calendar (.ics) → With an account.
Among the 146 studies testing Immune checkpoint inhibitors in Rectal Neoplasms, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This is a prospective, single-arm, biomarker-stratified, multicenter phase 2 clinical trial. All enrolled patients first receive short-course radiotherapy (SCRT), followed by measurement of serum β-hydroxybutyrate (β-HB) levels to calculate the post-radiotherapy elevation rate. Patients are stratified into an β-HB-positive stratum (elevation significantly) and an β-HB-negative stratum (no elevation), then randomized 1:1 within each stratum to receive either perioperative chemotherapy plus PD-1 inhibitor or perioperative chemotherapy alone.
The primary endpoint is the complete response (CR) rate, defined as the composite of pathological complete response (pCR) and clinical complete response (cCR). The study aims to evaluate the efficacy and safety of adding PD-1 inhibitor to perioperative chemotherapy in LARC, and to validate post-radiotherapy β-HB elevation as a predictive biomarker for immunotherapy benefit.
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.
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.
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.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
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.
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.
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.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
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.
β-HB-Positive (β-HB Elevation significantly) * Radiation: Short-course radiotherapy (SCRT): 25 Gy delivered in 5 fractions over 1 week. * Chemotherapy: 6 cycles of CAPEOX (Capecitabine 1000 mg/m² PO BID D1-14 + Oxaliplatin 130 mg/m² IV D1, q3w) at investigator's discretion. * PD-1 Inhibitor: Approved anti-PD-1 monoclonal antibody, administered on Day 1 of each chemotherapy cycle for 6 cycles. Dose may be delayed for immune-related adverse events (irAEs) (max delay ≤6 weeks). * Procedure: Restaging after 6 cycles; TME surgery or Watch \& Wait strategy per multidisciplinary evaluation.
Radiation: Short-course radiotherapy · Drug: Capecitabine · Drug: Oxaliplatin · Procedure: TME surgery · Drug: PD -1/PD-L1 monoclonal antibody · Other: Watch & Wait strategy
β-HB-Positive (β-HB Elevation significantly) * Radiation: Short-course radiotherapy (SCRT): 25 Gy delivered in 5 fractions over 1 week. * Chemotherapy: 6 cycles of CAPEOX (Capecitabine 1000 mg/m² PO BID D1-14 + Oxaliplatin 130 mg/m² IV D1, q3w) at investigator's discretion. * Procedure: Restaging after 6 cycles; TME surgery or Watch \& Wait strategy per multidisciplinary evaluation.
Radiation: Short-course radiotherapy · Drug: Capecitabine · Drug: Oxaliplatin · Procedure: TME surgery · Other: Watch & Wait strategy
β-HB-Negative (β-HB no Elevation) * Radiation: Short-course radiotherapy (SCRT): 25 Gy delivered in 5 fractions over 1 week. * Chemotherapy: 6 cycles of CAPEOX (Capecitabine 1000 mg/m² PO BID D1-14 + Oxaliplatin 130 mg/m² IV D1, q3w) at investigator's discretion. * PD-1 Inhibitor: Approved anti-PD-1 monoclonal antibody, administered on Day 1 of each chemotherapy cycle for 6 cycles. Dose may be delayed for immune-related adverse events (irAEs) (max delay ≤6 weeks). * Procedure: Restaging after 6 cycles; TME surgery or Watch \& Wait strategy per multidisciplinary evaluation.
Radiation: Short-course radiotherapy · Drug: Capecitabine · Drug: Oxaliplatin · Procedure: TME surgery · Drug: PD -1/PD-L1 monoclonal antibody · Other: Watch & Wait strategy
β-HB-Negative (β-HB no Elevation) * Radiation: Short-course radiotherapy (SCRT): 25 Gy delivered in 5 fractions over 1 week. * Chemotherapy: 6 cycles of CAPEOX (Capecitabine 1000 mg/m² PO BID D1-14 + Oxaliplatin 130 mg/m² IV D1, q3w) at investigator's discretion. * Procedure: Restaging after 6 cycles; TME surgery or Watch \& Wait strategy per multidisciplinary evaluation.
Radiation: Short-course radiotherapy · Drug: Capecitabine · Drug: Oxaliplatin · Procedure: TME surgery · Other: Watch & Wait strategy
Eligible subjects will receive short-course radiotherapy (SCRT). One week after the end of treatment, subjects continued to receive neoadjuvant chemotherapy.
1000mg/m2, bid, po, d1-14,q3w
130mg/m2, ivgtt, d1,q3w
The surgery was performed 1 week after the end of neoadjuvant therapy.
Drug page: Immune checkpoint inhibitors
200 mg via intravenous infusion every 3 weeks (q3w) for 6 cycles, initiated 1 week after radiotherapy completion.
The Watch \& Wait (W\&W) strategy is an organ-preserving clinical management approach for patients with locally advanced rectal cancer who achieve a clinical complete response (cCR) after neoadjuvant therapy. In this strategy, definitive surgical resection (total mesorectal excision, TME) is withheld, and patients are instead managed with a standardized, intensive surveillance regimen to monitor for disease regrowth.
complete response (CR) rate
Defined as pathological complete response (pCR) + Clinical complete response (cCR)
Time frame: an expected average of 12 months
3-year disease-Free Survival
The time from the first day of disease free (operation date) to local or distant recurrence, or the death event caused by any reason, whichever occurs first
Time frame: an expected average of 3 years
Overall Survival
The time from the date of randomization to the death caused by any cause
Time frame: an expected average of 5 years
Adverse events (AEs) were graded according to the NCI CTCAE version 5·0
Adverse events and surgical safety
Time frame: an expected average of 1.5 years
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Oct 2027, 11 months later.
Of 227 non-industry phase 2 interventional studies under Rectal Neoplasms, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 80. This study's planned 11 months is below that.
Counting every sponsor, half of 241 studies reached it within 46 months; a quarter within 31 and three quarters within 75.
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 ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Immune checkpoint inhibitors
Tao Zhang