A Phase 2 interventional study of Neoadjuvant therapy with PD-L1 inhibitor in Colorectal Cancer, Mismatch Repair-deficient (dMMR) and Microsatellite Instability-high (MSI-H), sponsored by Third Affiliated Hospital, Sun Yat-Sen University. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-05-12.
Sponsored by Third Affiliated Hospital, Sun Yat-Sen University · Phase 2, Interventional, and Treatment
Among 376 studies testing Immune checkpoint inhibitors in Colorectal Neoplasms — 158 open to participants now, 210 under way, 24 of them phase 3. A drug class: Immune checkpoint inhibitors · Colorectal Neoplasms.
Among the 376 studies testing Immune checkpoint inhibitors in Colorectal Neoplasms, this one is the 287th largest by planned enrollment, is one of 31 that started in 2022, is one of 217 in phase 2, and was the 171st registered.
6,544 studies on the registry are indexed under Colorectal Neoplasms; 1,666 are open to participants now.
Browse Colorectal Neoplasms studies →158 of the 376 studies testing Immune checkpoint inhibitors in Colorectal Neoplasms are open now, in 12 countries. Recruiting first, the newest first:
National Cancer Institute (NCI) · Sites in United States
Ages 18+
Fudan University · Sites in China
Ages 18+
Nanjing Leads Biolabs Co.,Ltd · Sites in China
Ages 18–75
Dan Feng · Sites in United States
Ages 18+
National Cancer Institute (NCI) · 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 1,184 Colorectal Neoplasms studies recruiting now, 767 (65%) set no upper age limit and 264 (22%) stop at 75 or younger; 48 take children under 18; 124 take healthy volunteers.
This study: 18 Years to 70 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.
376 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 1 122 · Phase 2 271 · Phase 3 33 · Phase 4 2
First in 2006; this study’s year is marked. 31 started in 2022.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 26 is below the median of 76 across 4,801 interventional studies indexed under Colorectal Neoplasms.
Median enrollment 48 across the 376 interventional studies. Of the 105 that completed or were terminated, 55 (52%) have results posted.
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104 of 376 have an industry lead sponsor. The 10 most frequent:
Third Affiliated Hospital, Sun Yat-Sen University is the lead sponsor of 133 studies on the registry; 35 are open to participants now.
Third Affiliated Hospital, Sun Yat-Sen University has 4 studies filed under Colorectal Neoplasms — fewer than ten, so there is no comparison to draw.
59 of the studies testing Immune checkpoint inhibitors in Colorectal Neoplasms that are under way reach primary completion within a year, 4 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05171660Phase 3Second Affiliated Hospital, School of Medicine, Zhejiang UniversityCombination With Sintilimab and XELOX+Bevacizumab as 1st Line Therapy in RAS-mutant Metastatic Colorectal Cancer | 2026-12-30 |
| NCT06280495Phase 3Sun Yat-sen UniversityNeoadjuvant Serplulimab & Bevacizumab With FOLFOX vs. FOLFOX Alone in RAS/BRAF WT, pMMR/MSS CRC Patients | 2026-12-31 |
| NCT02997228Phase 3National Cancer Institute (NCI)Testing the Addition of Atezolizumab to Combination Chemotherapy or Atezolizumab Alone for Metastatic Colon or Rectal Cancer, the COMMIT Study | 2027-06-01 |
| NCT06520683Phase 3Sun Yat-sen UniversityAdjuvant PD-1 Blockade for High-risk Stage-II DMMR/MSI-H Colorectal Cancer | 2027-11-01 |
| NCT06885385Shanghai Junshi Bioscience Co., Ltd.A Phase 2 Study Evaluating the Safety and Efficacy of JS207 With or Without JS015 in Combination With Chemotherapy in Patients With Colorectal Cancer | 2026-11-27 |
Add all 59 to your calendar (.ics) → With an account.
Among the 376 studies testing Immune checkpoint inhibitors in Colorectal Neoplasms, from their registry updates:
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Colorectal cancer (CRC) is one of the most common malignant tumours of human beings. Mismatch Repair-deficient (dMMR)/ Microsatellite Instability-high (MSI-H) CRC is a specific subtype of CRC, which accounts for approximately 15% of all CRC patients, and can not benefit from 5-fluorouracil (5-FU) adjuvant chemotherapy. Once patients have distant metastases, they are not sensitive to traditional palliative chemotherapy, and thus lead to much worse prognosis than that of mismatch repair-proficient (pMMR)/ microsatellite stability (MSS). A phase II clinical study of anti-PD-1 immunotherapy based on mismatch repair (MMR) status published in "N Engl J Med" showed that the objective response rate (ORR) of advanced colorectal cancer patients with dMMR received anti-PD-1 is 40%, and a longer response time can be obtained compared to conventional chemotherapy. Another study (ClinicalTrials.gov, NCT03926338) which investigating the effect of neoadjuvant PD-1 blockade with toripalimab, with or without celecoxib, on mismatch repair-deficient or microsatellite instability-high, locally advanced, colorectal cancer. The result revealed that all 34 patients had an R0 resection. 15 of 17 patients (88%) in the toripalimab plus celecoxib group and 11 of 17 patients (65%) in the toripalimab monotherapy group had a pathological complete response.
In theory, anti-PD-L1 drugs should have fewer immune side-effects than anti-PD-1 drugs. However, there are no reports of anti-PD-L1 neoadjuvant therapy for the dMMR/MSI-H colorectal cancer. Therefore, the aim of this study was to investigate the efficacy and safety of anti-PD-L1 monoclonal antibody (Envafolimab) as neoadjuvant immuntherapy for resectable local advanced colorectal cancer patient with the dMMR/MSI-H.
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.
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.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
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.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
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.
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.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
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.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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.
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.
Neoadjuvant therapy with PD-L1 inhibitor (Envafolimab)
Drug: Neoadjuvant therapy with PD-L1 inhibitor
Drug page: Immune checkpoint inhibitors
Neoadjuvant therapy with PD-L1 inhibitor (Envafolimab), 300mg, Q3W for 4 cycles
Pathological complete response (pCR) rates
Proportion of patients experiencing a pCR to perioperative PD-L1 antibody
Time frame: 1 year
Major pathological response rates
The proportion of patients experiencing a major pathological response to perioperative PD-L1 antibody
Time frame: 1 year
R0 resection rates
The proportion of patients experiencing a R0 resection after perioperative treatment with PD-L1 antibody
Time frame: 1 year
Disease-free survival (DFS)
Defined as the time from randomization to relapse, metastasis or death from any cause
Time frame: 3 years
Overall survival (OS)
Defined as the time from randomization to death from any cause
Time frame: 5 years
Drug Safety
Assessed by evaluation of treatment-related adverse events
Time frame: 1 year
Drug feasibility
Any treatment-related delays in the planned surgery of no more than 28 days after the last preoperative toripalimab dose
Time frame: 1 year
Plan to share: Undecided
No publications or documents are linked to this record.
Started May 2022 (actual). Primary completion is estimated for Jun 2024, 25 months after the start.
Of 498 non-industry phase 2 interventional studies under Colorectal Neoplasms, half reached primary completion within 55 months of starting (the median), counting those still running; a quarter within 33 and three quarters within 75. This study's planned 25 months is below that.
Counting every sponsor, half of 618 studies reached it within 49 months; a quarter within 31 and three quarters within 75.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in May 2022. 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
Third Affiliated Hospital, Sun Yat-Sen University →