AIM-Harvard/TrialPanorama-filtered huggingface dataset:
Trial: NCT05327972
Drug: The investigational medicinal product is incobotulinumtoxinA (XEOMIN®).
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Two milliliters of a mixture comprised of XEOMIN® 100 U and saline solution 0.9% will be once injected in the supra-spinatus muscle using ultrasonography guidance.
Trial: NCT04872881
Drug: Fentanyl
RxNorm normalized name: Fentanyl
DrugBank: Fentanyl (DB00813)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: 1mcg/kg fentanyl of 0.5 mg/10ml injectable solution was given.
Trial: NCT05755672
Drug: Chemotherapy
RxNorm normalized name: Chemotherapy Glove SML
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Neo-adjuvant and adjuvant chemotherapy with curative intent, according to the current clinical practice guidelines
Trial: NCT05248139
Drug: Intraoperative delivery of medication, Kenalog (Triamcinolone)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Subconjunctival triamcinolone acetonide 4 mg (0.4 mL of 10 mg/mL solution), single-dose injected 6-8 mm inferior to the inferior limbus with a bent 27-gauge needle at completion of cataract surgery.
Trial: NCT05248139
Drug: Topical post-operative eyedrops, Prednisolone acetate
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Standard of care Presnisolone acetate 1% ophthalmic drop taper: 4 times per day for first week, then tapering one drop per week for 3 additional weeks. Discontinued after 4 weeks.
Trial: NCT04924998
Drug: current treatment of AL-CM
RxNorm normalized name: Hongo Killer Treatment
FDA approved: no
EMA approved: no
PMDA approved: no
Description: current treatment of AL-CM
Trial: NCT05328583
Drug: HRS5685；Placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Drug1: HRS5685 Single dose in group A-F and multiple doses in group G-H~Drug2: Placebo Single dose in group A-F and multiple doses in group G-H
Trial: NCT06566586
Drug: TQB3702 tablets+Chemotherapy regimen
RxNorm normalized name: aspirin Oral Tablet [Anacin Aspirin Regimen]
FDA approved: no
EMA approved: no
PMDA approved: no
Description: TQB3702 tablets: Tyrosine kinase inhibitor；~Chemotherapy regimen：inhibiting tumor cell proliferation, suppressing DNA synthesis, inducing cell apoptosis, enhancing immune system function, and inhibiting angiogenesis；
Trial: NCT04386642
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: normal saline solution in a clear 50-ml syringe
Trial: NCT04913649
Drug: Ferric Derisomaltose 100 MG/ML
RxNorm normalized name: ferric derisomaltose 100 MG/ML
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Postoperative treatment with a single dose IVI (ferric derisomaltose), with a dose of 20mg/kg in approximately 60 minutes.
Trial: NCT00416377
Drug: prednisolone
RxNorm normalized name: Prednisolone
DrugBank: Prednisolone acetate (DB15566)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT04891484
Drug: Saline group
FDA approved: no
EMA approved: no
PMDA approved: no
Description: patients will be injected with 10 ml normal saline intravenous 5 min before spinal anesthesia
Trial: NCT04631549
Drug: SHR3680
FDA approved: no
EMA approved: no
PMDA approved: no
Description: SHR3680, PO, single dose
Trial: NCT05001854
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 100 μg every 6 hours of placebo per os
Trial: NCT05950113
Drug: Cyclophosphamide
RxNorm normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Receive IV
Trial: NCT04842383
Drug: Hemp Oil
RxNorm normalized name: HEMP OIL
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Hemp oil extract rich in varins (THCV and CBDV) as well as cannabidiol (CBD) in combination with 3% peppermint oil extract
Trial: NCT05186506
Drug: Ensatinib
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 225 mg administered once daily orally for two years.
Trial: NCT05186506
Drug: chemotherapy
RxNorm normalized name: Chemotherapy Glove SML
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Pemetrexed : Participants will receive 500 mg/m\^2, day 1 , Q21D , until completion of treatment period (4 cycles), recurrence of disease, unacceptable toxicity, withdrawal of consent, or death, whichever occurs first.~Cisplatin :Participants will receive 75 mg/m\^2, day 1 , 21 days/cycle, Q21D , until completion of treatment period (4 cycles), recurrence of disease, unacceptable toxicity, withdrawal of consent, or death, whichever occurs first.~Paclitaxel: Participants will receive 175 mg/ m\^2, day 1 , 21 days/cycle, Q21D , until completion of treatment period (4 cycles), recurrence of disease, unacceptable toxicity, withdrawal of consent, or death, whichever occurs first.~carboplatin AUC= 5 mg/ mL/min, intravenously guttae, day 1 ,Q21D ，until completion of treatment period (4 cycles), recurrence of disease, unacceptable toxicity, withdrawal of consent, or death, whichever occurs first.
Trial: NCT06726161
Drug: RYZ801
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Ac-225
Trial: NCT05527483
Drug: [68Ga]PSMA
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Patients will receive up to 6 mCi of \[Ga-68\]PSMA delivered as an intravenous (IV) bolus injection, followed by digital PET/CT imaging
Trial: NCT05527483
Drug: Flourine-18 [F-18] Sodium Fluoride (NaF)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Patients will receive 8-12 mCi of \[F-18\]NaF delivered as an intravenous (IV) bolus injection, followed by digital PET/CT imaging.
Trial: NCT05003713
Drug: CORT125236
FDA approved: no
EMA approved: no
PMDA approved: no
Description: CORT125236 Lipid Capsule Formulation 10-60 mg for oral administration
Trial: NCT05003713
Drug: Placebo matching CORT125236
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo matching CORT125236 Lipid Capsule Formulation 10-60 mg for oral administration
Trial: NCT06503029
Drug: Listeren Mouthwash
RxNorm normalized name: Listerine Mouthwash Product
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Listeren Mouthwash is used as a cleaning method for orthodontic clear aligners. It includes Eucalyptol and Menthol as active ingredients.
Trial: NCT05164627
Drug: Normal saline
RxNorm normalized name: Normal Saline Flush
FDA approved: no
EMA approved: no
PMDA approved: no
Description: After patient arrival at the PACU, Paediatric Anaesthesia Emergence Delirium (PAED) scale ,Ramsay sedation scores (RSS), emergence agitation, HR, and mean arterial blood pressure (MAP) were recorded every 5 min during the first 30 min, then every 10 min for the remaining 30 min of the recovery room stay. Patients were then transferred to the ward. All postoperative observations and scores were performed by the same anesthesiologist who was blinded to the group assignment
Trial: NCT00120913
Drug: Birth control pills
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT04536454
Drug: [18F]FPyGal
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Radiotracer for PET-imaging
Trial: NCT04987658
Drug: OLZ/SAM
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Olanzapine and Samidorphan taken once daily over a max period of 21 days
Trial: NCT04807335
Drug: sufentanil
RxNorm normalized name: Sufentanil
DrugBank: Sufentanil (DB00708)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: iv single dose
Trial: NCT06092931
Drug: Rosuvastatin
RxNorm normalized name: Rosuvastatin
DrugBank: Rosuvastatin (DB01098)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Oral tablets
Trial: NCT06486974
Drug: NaF
RxNorm normalized name: Renaf
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Group 1 will be instructed to brush their teeth twice daily/2 minutes each time for the duration of this study
Trial: NCT06486974
Drug: Na MFP
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Group 2 will be instructed to brush their teeth twice daily/2 minutes each time for the duration of this study
Trial: NCT05038969
Drug: Stomopral
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 1 capsule contains 40 mg Esomeprazole
Trial: NCT04694027
Drug: VitaE
RxNorm normalized name: Oriental arborvitae pollen extract
FDA approved: no
EMA approved: no
PMDA approved: no
Description: vitamin e 400 mg
Trial: NCT06307795
Drug: ANS014004
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Varying doses of ANS014004
Trial: NCT04705987
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo 1c/24h Treatment 8 weeks
Trial: NCT06650930
Drug: Oral calcium carbonate
RxNorm normalized name: Calcium Carbonate
DrugBank: Calcium carbonate (DB06724)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: All participants receive a single, open-label dose of oral calcium carbonate 3000mg
Trial: NCT06091436
Drug: GenSci094
FDA approved: no
EMA approved: no
PMDA approved: no
Description: On the morning of day 2 or 3 of the menstrual cycle (Stimulation Day 1), a single SC injection of 150 μg or 100μg (0.5 mL) GenSci094 was administered in the abdominal wall.
Trial: NCT06091436
Drug: Placebo GenSci094
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Pre-filled syringe containing an identical solution when compared to GenSci094. On the morning of day 2 or 3 of the menstrual cycle (Stimulation Day 1), a single SC injection was administered in the abdominal wall.
Trial: NCT04894123
Drug: Trifluridine/Tipiracil
RxNorm normalized name: TRIFLURIDINE/TIPIRACIL
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Trifluridine/tipiracil : 35 mg/m² orally twice a day from day 1 to day 5 every 14 days.~If oxaliplatin is stopped or it is not indicated, trifluridine/tipiracil in monotherapy 35 mg/m² orally twice a day between days 1-5 and days 8-12; repeated every 28 days.
Trial: NCT06583330
Drug: Low Molecular Weight Heparin (dalteparin)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: All patients initiated low molecular weight heparin for drug prevention within 24 hours after surgery. The prevention course for the experimental group patients was 14 days, while the prevention course for the control group patients was 28 days. Low molecular weight heparin is administered subcutaneously once daily at a dose of 0.3ml.
Trial: NCT06583265
Drug: Observational
FDA approved: no
EMA approved: no
PMDA approved: no
Description: To observe if endometrial compaction ≥ 5% in down regulated FET cycles increases clinical pregnancy rate.
Trial: NCT06583902
Drug: Intravenous iron
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Patients with an absolute deficiency (ferritin ≤100 μg/L) or functional deficiency (ferritin ≤ 300 μg/L with transferrin saturation ≤20%) receive iron supplementation, through a single administration of an iron preparation for intravenous use administered according to the doses present in the technical data sheet.
Trial: NCT05192304
Drug: TPN-672
FDA approved: no
EMA approved: no
PMDA approved: no
Description: single dose of TPN-672 maleate tablet
Trial: NCT04895345
Drug: TQB2450
FDA approved: no
EMA approved: no
PMDA approved: no
Description: TQB2450 is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1), which prevents PD-L1 from binding to PD-1 and B7.1 receptors on T cell surface, restores T cell activity, thus enhancing immune response and has potential to treat various types of tumors.
Trial: NCT06629116
Drug: Patients with AIS receive intravascular therapy, and within 10 minutes after the surgery, they are administered 100ml of 20% human albumin intravenously (infused within 30 minutes).
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Whether to administer albumin to AIS patients after intravascular thrombectomy and reperfusion.
Trial: NCT06630572
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Patients randomized to receive Placebo for 14 days
Trial: NCT06206915
Drug: XZ120 injection
FDA approved: no
EMA approved: no
PMDA approved: no
Description: in Part One：XZ120 monotherapy, IV, no less than 60min, Q3W dose escalation study: 4 dose group (0.75 mg/m2, 1.5 mg/m2, 2.25 mg/m2, 3.0 mg/m2) Dose expansion study: MTD dose
Trial: NCT05761223
Drug: Phase Ib dose-expansion of FB849 monotherapy
FDA approved: no
EMA approved: no
PMDA approved: no
Description: At recommended dose for expansion cohort once daily
Trial: NCT04985318
Drug: Cablivi®
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Intervention with Cablivi® take place outside of the study
Trial: NCT05393895
Drug: CSF-1
RxNorm normalized name: CSF-1
FDA approved: no
EMA approved: no
PMDA approved: no
Description: One drop bilaterally twice daily for approximately 6 weeks
Trial: NCT05393895
Drug: Vehicle
RxNorm normalized name: Drug vehicle
FDA approved: no
EMA approved: no
PMDA approved: no
Description: One drop bilaterally twice daily for approximately 6 weeks
Trial: NCT06712654
Drug: AP306 75mg TID
FDA approved: no
EMA approved: no
PMDA approved: no
Description: receiving orally AP306 75mg (one tablet), three times a day
Trial: NCT06712654
Drug: AP306 100mg TID
FDA approved: no
EMA approved: no
PMDA approved: no
Description: receiving orally AP306 100 mg (one tablet), three times a day.
Trial: NCT06712654
Drug: AP306 125mg BID
FDA approved: no
EMA approved: no
PMDA approved: no
Description: receiving orally AP306 125 mg (one tablet), three times a day, among which one is a placebo tablet
Trial: NCT06712654
Drug: AP306 150mg BID
FDA approved: no
EMA approved: no
PMDA approved: no
Description: receiving orally AP306 150 mg (one tablet), three times a day, among which one is a placebo tablet
Trial: NCT06712654
Drug: Placebo TID
FDA approved: no
EMA approved: no
PMDA approved: no
Description: receiving orally one placebo tablet of AP306, three times a day
Trial: NCT06713057
Drug: Cyclophosphamide+Pemetrexed+5-Fluorouracil
FDA approved: no
EMA approved: no
PMDA approved: no
Description: IV or PO
Trial: NCT06713057
Drug: Cyclophosphamide+Doxorubicin+5-Fluorouracil
FDA approved: no
EMA approved: no
PMDA approved: no
Description: IV or PO
Trial: NCT06713057
Drug: Doxorubicin + Cisplatin
RxNorm normalized name: Cisplatin
DrugBank: Cisplatin (DB00515)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: IV or PO
Trial: NCT06713057
Drug: Doxorubicin + Cyclophosphamide + Cisplatin
RxNorm normalized name: Cisplatin
DrugBank: Cisplatin (DB00515)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: IV or PO
Trial: NCT06713057
Drug: Docetaxel + Doxorubicin
RxNorm normalized name: Docetaxel
DrugBank: Docetaxel (DB01248)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: IV or PO
Trial: NCT06713057
Drug: Paclitaxel + Doxorubicin
RxNorm normalized name: Paclitaxel
DrugBank: Paclitaxel (DB01229)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: IV or PO
Trial: NCT05515120
Drug: Acenocoumarol Oral Tablet
RxNorm normalized name: acenocoumarol Oral Tablet
FDA approved: no
EMA approved: no
PMDA approved: no
Description: It was adopted an equal allocation of patients to each treatment (i.e., 1:1 randomization)
Trial: NCT06714032
Drug: TCM plus conventional drug
FDA approved: no
EMA approved: no
PMDA approved: no
Description: All patients were treated according to international guidelines. The Experimental group will receive TCM according to the TCM syndrome.
Trial: NCT06714032
Drug: TCM placebo plus conventional drug
FDA approved: no
EMA approved: no
PMDA approved: no
Description: All patients were treated according to international guidelines. The control group will receive TCM placebo according to the TCM syndrome.
Trial: NCT00002138
Drug: Tecogalan sodium
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT06714084
Drug: maintenance therapy
RxNorm normalized name: Dental Resources Perio Maintenance Rinse
FDA approved: no
EMA approved: no
PMDA approved: no
Description: one years of maintenance therapy with carbonilumab alone will be implemented to patients with advanced cervical cancer receiving standard concurrent chemoradiotherapy
Trial: NCT00001023
Drug: Clarithromycin
RxNorm normalized name: Clarithromycin
DrugBank: Clarithromycin (DB01211)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT00001023
Drug: Azithromycin
RxNorm normalized name: Azithromycin
DrugBank: Azithromycin (DB00207)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Trial: NCT05763004
Drug: IOS-1002 + KEYTRUDA® (pembrolizumab)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: combination therapy
Trial: NCT04891354
Drug: PDNO
RxNorm normalized name: Prednisolone
DrugBank: Prednisolone acetate (DB15566)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: PDNO consists of propylene glycol (1,2-propanediol, PD) chemically combined with NO (to be donated). The drug substance is formulated as an inherent mixture of 4 structure analogues. The mixture consists of an equilibrium of the 2 regioisomers 1-(nitrosooxy) propan-2-ol and 2-(nitrosooxy) propan-1-ol. In addition, each regioisomer is a racemic mixture.
Trial: NCT05268172
Drug: IFN-γ and CIK cells, Tcm cells or CAR T cells
FDA approved: no
EMA approved: no
PMDA approved: no
Description: A 50ng/ mL IFN-γ solution was prepared, and the required volume of IFN-γ solution was calculated according to the final concentration of 5ng/ mL according to the volume of pleural fluid or ascites of the patient. CIK cells were injected 1.0-2.0×109 on the second day and review three days later.T cells and CAR T cells were selected sequentially according to the re-examination of pleural fluid or ascites.
Trial: NCT05349864
Drug: PF-07284890 Treatment C
FDA approved: no
EMA approved: no
PMDA approved: no
Description: PF-07284890 tablet after high fat meal
Trial: NCT05507463
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo
Trial: NCT05835180
Drug: TVB-2640 - 50 mg
FDA approved: no
EMA approved: no
PMDA approved: no
Description: TVB-2640 -50 mg administered orally once daily
Trial: NCT05954169
Drug: SHR4640
FDA approved: no
EMA approved: no
PMDA approved: no
Description: SHR4640 single-dose
Trial: NCT04700046
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: The placebo capsules contain the same ingredients as the active formulation with the exception of mexiletine
Trial: NCT05215834
Drug: Remifentanil
RxNorm normalized name: Remifentanil
DrugBank: Remifentanil (DB00899)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 1. Remimazolm and Remifentanil (RR group): anesthesia was induced with remimazolam 6 mg/kg/h by continuous intravenous (IV) infusion and with the effect-site concentration of remifentanil 4 ng/ml and until the loss of consciousness (LoC), followed by remimazolam 1-2 mg/kg/h and remifentanil 3 ng/ml until the end of surgery.~2. Propofol and Remifentanil (PR group), anesthesia was induced with the effect-site concentration of propofol of 6.0 μg/ml and remifentanil 4 ng/ml, and until the loss of consciousness (LoC), followed by the effect-site concentration of propofol of 2-4 μg/ml and remifentanil 3 ng/ml until the end of surgery.
Trial: NCT06288321
Drug: Microdrop Mydrin-P
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Microdrop Mydrin-P consists of around one third of the standard Mydrin-P drop size. Drop volume measurement was performed using a precision weight scale (Sartorius) with accuracy up to 0.001g. The microdrop administration was conducted via attachment of a 16 gauge needle to a 1ml syringe.
Trial: NCT06288321
Drug: Standard Mydrin-P
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Standard Mydrin-P is the standard mydriatic used for retinopathy of prematurity exam as per our local usual practice.
Trial: NCT06417489
Drug: Sequential treatment group
RxNorm normalized name: Hongo Killer Treatment
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Metformin, the dose from the first to second week is 500mg bid, and the dose from the third to fourth week is 1000mg bid. If the maximum dose of metformin cannot be tolerated, the researcher shall increase the dosage according to the patient\&#39;s tolerance situation. The minimum dose is 1000mg/day. After the fourth week of treatment, blood glucose levels were measured. For those whose blood glucose levels did not meet the standard (fasting blood glucose (FPG)\&gt;7mmol/L, postprandial blood glucose (PPG)\&gt;10mmol/L), 10 mg qd of Henagliflozin Prolinewas sequentially added. If the blood glucose levels did not meet the standard after 4 weeks of treatment (FPG\&gt;7mmol/L, PPG\&gt;10mmol/L), 100 mg qd of Ruigeliflozin was added
Trial: NCT06292650
Drug: ZM-02-L
RxNorm normalized name: L
FDA approved: no
EMA approved: no
PMDA approved: no
Description: rAAV-PsCatCh2.0 intravitreal injection of low dose
Trial: NCT04864509
Drug: Melatonin 10 MG
RxNorm normalized name: melatonin 10 MG
DrugBank: Melatonin (DB01065)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Nightly dose
Trial: NCT04864509
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Nightly dose
Trial: NCT02989012
Drug: GanMaoKangNing Granules
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 3 times a day, 2 bags each time.
Trial: NCT02989012
Drug: Analogous GanMaoKangNing Granules
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 3 times a day, 2 bags each time.
Trial: NCT04786795
Drug: Oryz-aspergillus Enzyme both Pancreatin Tablet and Ursodeoxycholic Acid Tablets
RxNorm normalized name: ursodeoxycholic acid
DrugBank: Ursodeoxycholic acid (DB01586)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: the control group takes Oryz-aspergillus Enzyme both Pancreatin Tablet and Ursodeoxycholic Acid Tablets. They were registered before medication and on days 14 and 28 after medication, and gastrointestinal symptoms were assessed at each follow-up visit
Trial: NCT05794750
Drug: AK104 injection
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Eligible subjects will receive short-course radiotherapy (SCRT), IMRT/VMAT, pelvic 25Gy/5f/1 week. Two weeks after the end of treatment, subjects continued to receive neoadjuvant chemotherapy combined with immunotherapy regimen for 4 cycles: AK104 10 mg/kg, intravenous infusion every 3 weeks (Q3W), plus CAPOX (capecitabine: 1000mg/m2, bid, po, d1-14, oxaliplatin: 130mg/m2, ivgtt, d1), Q3W. Neoadjuvant therapy was assessed 2 weeks after the end of neoadjuvant therapy, and TME surgery was performed 4 weeks after the end of neoadjuvant therapy (R0 surgery was performed).
Trial: NCT05794750
Drug: Capecitabine
RxNorm normalized name: Capecitabine
DrugBank: Capecitabine (DB01101)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Eligible subjects will receive short-course radiotherapy (SCRT), IMRT/VMAT, pelvic 25Gy/5f/1 week. Two weeks after the end of treatment, subjects continued to receive neoadjuvant chemotherapy combined with immunotherapy regimen for 4 cycles: AK104 10 mg/kg, intravenous infusion every 3 weeks (Q3W), plus CAPOX (capecitabine: 1000mg/m2, bid, po, d1-14, oxaliplatin: 130mg/m2, ivgtt, d1), Q3W. Neoadjuvant therapy was assessed 2 weeks after the end of neoadjuvant therapy, and TME surgery was performed 4 weeks after the end of neoadjuvant therapy (R0 surgery was performed).
Trial: NCT04908605
Drug: Melatonin
RxNorm normalized name: Melatonin
DrugBank: Melatonin (DB01065)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Every patient will be given melatonin 5 mg tablet
Trial: NCT04908605
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Every patient will be given a matching placebo tablet